Publishes Resolution No. 333-2013 (COMIECO-LXVI) of 12/12/2013 and annexes: Reg.RTCA 11.03.59:11 Pharmaceutical Products, Medicines for human use. Req. Sanitary Reg. Annex 1. Procedure for Mutual Recognition of Sanitary Reg. Medications Annex 2N° 38414-COMEX-MEIC-S
(This executive decree was repealed by article 2 of executive decree No. 43259 of September 27, 2021, “Published resolution No. 446-2021 (COMIECO-XCIV) of 04/28/2021 Annex I: Central American Technical Regulation RTCA 11.03.59:18 Pharmaceutical Products. Medications for Human Use. Sanitary Registration Requirements ” Annex II: Mutual Recognition of Registration”)
THE PRESIDENT OF THE REPUBLIC
AND THE MINISTERS OF FOREIGN TRADE,
OF ECONOMY, INDUSTRY AND COMMERCE AND HEALTH
In accordance with the powers and attributions granted by articles 50, 140 subsections 3), 8), 10), 18) and 20); and 146 of the Political Constitution; articles 4, 25, 27 paragraph 1, 28 paragraph 2 subsection b) of the General Law of Public Administration, Law No. 6227 of May 2, 1978; Articles 1, 3, 5, 7, 15, 26, 30, 36, 37, 38, 39, 46, 52 and 55 of the Protocol to the General Treaty on Central American Economic Integration, Approval Law No. 7629 of September 26, nineteen ninety six; Y
Whereas :
I. -That the Council of Ministers of Economic Integration (COMIECO), through Resolution No. 333-2013 (COMIECO-LXVI) dated December 12, 2013; within the framework of the process of forming a Central American Customs Union, approved the “Central American Technical Regulation RTCA 11.03.59:11 Pharmaceutical Products, Medications for human use. Sanitary Registration Requirements” (Annex 1) and the “Procedure for Mutual Recognition Sanitary Registry of Medicines for Human Use” (Annex 2), both in the form in which they appear in the Annexes of this Resolution.
II. – That in compliance with what is indicated in said Resolution, its publication is proceeded.
Therefore;
They decree:
Publication of Resolution No. 333-2013 (COMIECO-LXVI) dated December 12, 2013 and its Annexes:
“Central American Technical Regulation RTCA 11.03.59:11 Pharmaceutical Products, Medicines for Human Use. Sanitary Registration Requirements”
(Annex 1) and the “Procedure for the Mutual Recognition of Sanitary Registrations of Medicines for Human Use” (Annex 2).
Article 1 – Publish Resolution No. 333-2013 (COMIECO-LXVI) of the Council of Ministers of Economic Integration dated December 12, 2013 and its Annexes: “Central American Technical Regulation RTCA 11.03.59:11 Pharmaceutical Products, Medicines for Use Sanitary Registration Requirements” (Annex 1) and the “Procedure for the Mutual Recognition of Sanitary Registrations of Medicines for Human Use” (Annex 2), which are transcribed below:
RESOLUTION No. 333-2013 (COMIECO-LXVI)
THE COUNCIL OF MINISTERS OF ECONOMIC INTEGRATION
CONSIDERING:
That in accordance with articles 38, 39 and 55 of the Protocol to the General Treaty of Central American Economic Integration -Guatemala Protocol- , modified by the Amendment of February 27, 2002, the Council of Ministers of Economic Integration (COMIECO) has under its competence matters of the Central American Economic Integration and, as such, it corresponds to approve the administrative acts of the Economic Subsystem;
That in accordance with article 15 of that same regional legal instrument, the States Parties are committed to establishing a Customs Union between their territories, which will be achieved gradually and progressively, on the basis of programs established for that purpose, approved by consensus;
That within the framework of the process of forming the Customs Union, the States Parties have reached important agreements on the Sanitary Registration Requirements for Medicines for Human Use, which require the approval of the Council;
That the States Parties, in their capacity as Members of the World Trade Organization (WTO), notified the Committee on Technical Barriers to Trade, in accordance with the provisions of the Agreement on Technical Barriers to Trade, of the Draft Central American Technical Regulation RTCA 11.03.59:11 Pharmaceutical Products. Medicines for Human Use. Sanitary Registration Requirements; and the Procedure for the Mutual Recognition of Sanitary Registrations of Medicines for Human Use;
That the States Parties granted a reasonable period of time to the Member States of the WTO to make observations on the notified draft Regulation as required by numeral 4), paragraph 9 of Article 2 of the Agreement on Technical Barriers to Trade, observations that were duly analyzed and addressed as appropriate;
That in accordance with the Agreement on Technical Barriers to Trade, Members shall provide for a reasonable period between the approval of technical regulations and their entry into force, in order to give producers time to adapt their products or their production methods to what is established in the regulations;
That in accordance with paragraph 3 of Article 55 of the Guatemala Protocol , the opinion of the Consultative Committee for Economic Integration was obtained ,
THEREFORE :
Based on the provisions of articles 1, 3, 5, 7, 15, 26, 30, 36, 37, 38, 39, 46, 52 and 55 of the Protocol to the General Treaty on Central American Economic Integration -Protocol of Guatemala-,
RESOLVES:
Approve the Central American Technical Regulation RTCA 11.03.59:.11 PHARMACEUTICAL PRODUCTS , MEDICINES FOR HUMAN USE, SANITARY REGISTRATION REQUIREMENTS, in the form that appears as Annex 1 of this Resolution and that forms an integral part of it.
In the case of medicines that are within the categories mentioned in numeral 7.11.3 that are going to be renewed and that originally their safety and efficacy have not been documented according to the sanitary requirements described in this regulation, they must present the established requirements. in said number.
In the case of El Salvador, the renewal of the registration carried out prior to the validity of this RTCA for the categories of medicines contemplated in numeral 7.{f.3 is excluded from what is established in this Regulation.
Approve the Procedure for the Mutual Recognition of the Sanitary Registry of Medicines for Human Use, as shown in Annex 2 to this Resolution.
This procedure does not apply to drug associations registered in El Salvador prior to the date of entry into force of the RTCA 11.03.59:11 Pharmaceutical Products. Medicines for Human Use. Sanitary Registration Requirements.
This Resolution will enter into force on June 12, 2014 and will be published by the States Parties.
image004.jpeg
Notwithstanding what is established in the previous numeral, this Resolution will not enter into force for Panama, until this Council issues. the corresponding administrative act, in accordance with the provisions of Article
Transitory of the Protocol of Incorporation of the Republic of Panama to the Subsystem of Economic Integration .
Panama, Republic of Panama , December 12, 2013.
undersigned Senior Advisor in Legal Affairs of the Secretariat for Central American Economic Integration ( SIEGA ) CERTIFIES : That the three (3) photocopies that precede this sheet of bond paper, printed only on the front , as well as the thirty – five (35 ) of two (2) annexes attached, printed only on the front, initialed and sealed with the SlECA seal , faithfully reproduce Resolution No. 333-2013 ( COMIECO – LXVI ) , adopted by the Council of Ministers of Economic Integration , on December 12 , 2013 . one thousand thirteen, of whose originals they reproduced . And to send to the States Parties for their corresponding publication , I issue this certified copy in Guatemala City , Guatemala , on December sixteenth , two thousand and thirteen . _–– —————
ANNEX 1 OF RESOLUTION No. 333-2013 (COMIECO-LXVI)
REGULATION
TECHNICAL
CENTRAL AMERICAN
RTCA 11.03.59:11
PHARMACEUTICAL PRODUCTS . MEDICINES FOR HUMAN USE. SANITARY REGISTRATION REQUIREMENTS.
CORRESPONDENCE: This Regulation has no correspondence with any other standard or
international regulation.
ICS 11.120.01 RTCA .11.03.59:11
Central American Technical Regulations , edited by:
. Ministry of Economy and Trade, MINECO
. Salvadoran Agency for Technical Regulation, OSARTEC
. Ministry of Development, Industry and Commerce. MIFIC
. Secretariat of Industry and Commerce, SIC
. Ministry of Economy, Industry and Commerce, MEIC
REPORT
The respective Technical Regulation Committees of the Central American countries and their successors are the organisms in charge of carrying out the study or the adoption of the Technical Regulations. They are made up of representatives from the Academic, Consumer, Private Enterprise and Government sectors.
This document was approved as Central American Technical Regulation, RTCA 11.03.59:11 Pharmaceutical Products. Drugs for Human Use. Sanitary Registration Requirements, by the Subgroup of Medications and Related Products and the Subgroup of Standardization Measures. The officialization of this technical regulation entails the ratification by the Council of Ministers of Central American Economic Integration (COMIECO).
PARTICIPATING MEMBERS
for Guatemala
Ministry of Public Health and Social Assistance
for El Salvador
National Directorate of Medicines
For Honduras
Health Secretary
For Costa Rica
Ministry of Health
For Nicaragua
Ministry of Health
1. OBJECT
Establish the conditions and requirements under which the sanitary registration of medicines for human use will be granted.
2. FIELD OF APPLICATION
It applies to medicines for human use that are manufactured or imported by natural or legal persons for their commercialization in the Central American territory. Master preparations are excluded from this Regulation.
GRADES:
1. Biological and biotechnological medicines shall be registered in accordance with the national legislation of each State Party.
2. As long as a State Party does not have a national legislation for the registration of biological and biotechnological medicines, the present regulation will apply to these products .
3. In the case of nutritional or food supplements, as long as there is no harmonized regulation at the regional level, the legislation of each state party will apply.
3. DOCUMENTS TO CONSULT
3.1 RTCA 11.03.39:06 Pharmaceutical Products. Validation Regulation of Analytical Methods for the Evaluation of the Quality of Medicines in force.
3.2 RTCA 11.01.02:04 Pharmaceutical Products. Labeling of Pharmaceutical Products for Human Use Current.
3.3 RTCA 11.01.04:10 Pharmaceutical Products. Stability Studies of Medicines for Current Human Use.
3.4 RTCA 11.03.56:09 Pharmaceutical Products. Medicines for Human Use. Current Quality Verification.
3.5 RTCA Pharmaceutical Products. Medicines for Human Use. Good Manufacturing Practices for the Pharmaceutical Industry Current .
4. DEFINITIONS
4.1 Packaging: all operations, including filling and labelling, necessary to convert a bulk product into a finished product.
4.2 Regulatory authority: authority responsible for health regulation in each country or region.
4.3 Regulatory authority of regional reference: it is the competent and efficient national regulatory authority in the performance of the health regulation functions recommended by PAHO/WHO, to guarantee the quality, safety and efficacy of medicines and biological products.
4.4 Strict regulatory authority : those defined in the WHO pharmaceutical prequalification process .
4.5 Good Manufacturing Practices: set of procedures and standards aimed at guaranteeing the uniform production of batches of pharmaceutical products that meet quality standards.
4.6 Certificate of free sale: document issued by the Regulatory Authority of the country or region of origin, or provenance, certifying that the drug referred to in the certificate has its current registration and is authorized for sale in that country; in the case of manufacture by third parties or subsidiaries and that the product is not marketed in the country of origin, it may be issued by the regulatory authority of the owner’s country.
4.7 Pharmaceutical product certificate: certification proposed by the WHO and issued by the Regulatory Authority of the country or region of origin or provenance, as part of the quality certification system for pharmaceutical products subject to international trade, in the case of manufacture by third parties or subsidiaries and that the product is not marketed in the country of origin, may be issued by the Regulatory Authority of the owner’s country.
4.8 Certificate of Good Manufacturing Practices: document issued by the Regulatory Authority of the country in which the manufacturing laboratory is located, certifying that the laboratory complies with Good Manufacturing Practices.
4.9 Co-packaging: form of presentation of two or more previously registered products that are marketed together for the treatment of a specific pathology.
4.10 Manufacturing contract: legal document entered into between the owner of the medication and the manufacturer in which the conditions, commitments and other circumstances for the manufacture of one or more products are established.
4.11 International non-proprietary name : name recommended by the WHO for the active ingredients of medicines.
4.12 Official document: that issued by the Competent Authority of the State.
4.13 Labeling or labeling: is any inscription or legend that identifies the product, that is printed, adhered or engraved on the primary container or packaging, and/or secondary container or packaging.
4.14 Primary container or primary packaging: container into which the medicine is placed directly in the finished dosage form.
4.15 Secondary container or secondary packaging: container within which the primary container containing the drug in its finished pharmaceutical form is placed for its distribution and marketing.
4.16 Chemical entity: functional group of the active principle that is responsible for the physiological or pharmacological action. It is understood that a chemical entity is shared by all those polymorphs, isomers and those derivatives with parts attached to the chemical entity that constitute an Ester, ether, salt (including a salt with hydrogen or coordinate bonds), or other non-covalent derivative such as complexes among others.
4.17 Pharmaceutical equivalent: medicine that contains identical amounts of the same active ingredients of the product to which it is equivalent, the same salt or ester of the active ingredient, in identical pharmaceutical forms, but which may or may not contain the same excipients. Consequently, two pharmaceutical equivalents may show different bioavailabilities, magnitudes, and time profiles of their pharmacological activities.
4.18 Manufacture or manufacture: all operations involved in the purchase of materials and products, production, conditioning, quality control , approval, storage, distribution of the finished product and related controls.
4.19 Manufacturing by third parties: national or foreign manufacturing carried out within the limits of a prior contract between the owner of the drug and the manufacturer, the owner being responsible for the product.
4.20 Insert, prospectus or instructions: technical-scientific information that is attached to the finished product, which must contain the necessary data for the safe and effective use of the medicine that it contains.
4.21 Manufacturing Laboratory: Authorized entity with facilities designed to carry out all operations involving the manufacture of pharmaceutical products.
4.22 Multi-origin drug: product that is pharmaceutically equivalent and that may or may not be therapeutically equivalent. Multisource drugs that are therapeutic equivalents are interchangeable.
4.23 Orphan drug: that which is intended for the treatment of rare, serious or incapacitating disease and whose commercial interest is unlikely, or without incentive measures . They are intended for a small group of patients but respond to public health needs.
4.24 Post-registration modifications: modifications to the sanitary registration of a pharmaceutical product after the granting of its registration.
4.25 Product monograph: scientific-technical description of the safety and efficacy profile of a medicine or pharmaceutical product.
4.26 Country of origin: country where the product is manufactured. In the event that more than w1 manufacturing laboratory is involved in the manufacture, the country of origin is the one in which the manufacture of at least the bulk product is carried out.
4.27 Country of origin: country from where the product is distributed, packaged or exported. Whenever these intervene in the manufacturing process; At least up to the primary packaging.
4.28 Country of the holder: country where the holder of the product is domiciled:
4.29 Master preparations : medicinal product prepared by the pharmacist in a pharmacy to meet a prescription or medical prescription for an individual patient. .
4.30 Active ingredient: substance endowed with a specific pharmacological effect or that without having activity, when administered in the body, acquires it after undergoing changes in its chemical structure. .
4.31 Pharmaceutical product or medicine : simple or compound substance ; natural, synthetic, or a mixture of them, with a defined pharmaceutical form, used to diagnose, treat, prevent diseases or modify a physiological function of the . Humans. .
4.32 Bulk product: product that has gone through all production phases except primary packaging.
4.33 Finished product : the one in its final container, labeled and ready to be distributed and marketed.
4.34 Responsible professional: professional pharmacist or pharmacist who is responsible for the health registration process before the Regulatory Authority, authorized by the owner of the medication or his legal representative through a power of attorney granted in accordance with the legislation of each State Party.
4.35 Sanitary registration: approval by the regulatory authority of a country for the marketing of a drug, once it has passed the evaluation process related to quality, efficacy and safety.
4.36 Legal representative: natural or legal person residing in the country where the registration is processed, authorized by the owner of the drug, through a power of attorney granted in accordance with the legislation of each State party, to respond to the Regulatory Authority.
4.37 Container-closure system: set of packaging materials that contain and protect the pharmaceutical form, includes both the primary packaging and the secondary packaging if the latter has the function of providing additional protection to the product.
4.38 Owner of the product or owner of the registration: natural or legal person who owns the product.
5. SYMBOLS AND ABBREVIATIONS
5.1. WHO: World Health Organization.
5.2. FDA: Food and Drug Administration of the United States of America.
5.3. ATC: Anatomical and Therapeutic Classification.
5.4. EMA: European Medicines Agency.
5.5. BPM: Good Manufacturing Practices.
5.6. INN: International Nonproprietary Name.
5.7. USPDI: Drug Information for Health Care Professionals.
5.8. AOAC: Association of Analytical Chemists.
6. GENERAL PROVISIONS
6.1. For the importation, distribution, commercialization, prescription and promotion, all medicines previously require their sanitary registration before the Regulatory Authority.
6.2. The sanitary registration of medicines will be valid for five years, the Regulatory Authority reserving the right to suspend or cancel it when there are duly justified health reasons of a scientific, technical or legal nature.
6.3. Any certificate or official document required must be valid at the time of presentation. Official documents will have the validity granted by the Regulatory Authority of the country where it is issued. In cases where the validity is not indicated, it will be 2 years for the purposes of the registration process, from the date of issue.
6.4. All official or legal documents must be presented in original or legalized copy in accordance with the legislation of each State Party.
The document must be submitted in Spanish/Castilian or accompanied by its respective translation issued in accordance with the legislation of each State Party.
6.5. Corrections in the certifications or in the official documents presented are not allowed, unless they are supported by the same authority that issued the original document.
6.6. All official or legal documents issued abroad must be legalized in compliance with specific national regulations.
6.7. In those cases in which it applies and for the purpose of registering a specific drug, the applicant will be allowed to refer to original, current documents that are in the files of the Regulatory Authority. In this case, the applicant must refer to the management in which the original document was delivered, presenting a simple photocopy of it.
6.8. In the cases of products to be registered that are not marketed in the country of origin or provenance, the Regulatory Authority will evaluate the justification provided.
6.9. They correspond to the same record:
6.9.1 Different commercial presentations of medicines with the same concentration and the same pharmaceutical form.
6.9.2 Medications with the same qualitative-quantitative formula and different flavor and/or color.
6.10. Official Books.
For the purposes of these regulations, the books recognized as official are:
6.10.1 For quality verification :
For the registration of medicines whose analysis methods for the finished product are pharmacopoeial, these must be described in the version that includes recent tests and specifications that allow evaluating the quality of the medicine for the specific pharmaceutical form. In case of not using the most up-to-date version, the applicant must justify this omission, declaring the pharmacopoeia and edition used, as long as it complies with the provisions of the current Central American Technical Regulation for Quality Verification and with the list of official books The Regulatory Authority will assess the justification provided. In the case of drugs described in more than one pharmacopoeia, the one with the most current and complete specifications should be used to verify the quality of the products.
The official books are the following:
a) German Pharmacopoeia
b) Argentine Pharmacopoeia
e) British Pharmacopoeia
d) United States Pharmacopeia (USP) and United States National Formulary ( USP /NF)
e) Spanish Pharmacopoeia
f) European Pharmacopoeia
g) French Pharmacopoeia
h) Swiss Pharmacopoeia
i) International Pharmacopoeia
j) Japanese Pharmacopoeia
k) Mexican Pharmacopoeia
i) Chinese Pharmacopoeia
m) Food Chemical Codex (FCC)
n) AOAC
o) and others that the countries agree to include by consensus.
6.10.2 For pharmacological evaluation:
The following literature may be used for the evaluation of the Extended Essay:
to. Drug Information for the Health Care Professionals (USPDI)
b. Drug Information (AHFS).
c. Martindale The extra Pharmacopoeia.
d Pharmacological Standards of Central America and the Dominican Republic.
and. Pharmacology books that are scientifically based.
F. Scientifically substantiated full journal articles.
6.11. The name of the drug to be registered must not cause confusion with another already registered, either in its written or pronounced form, therefore the name of the drug to be registered must meet the following conditions:
6.11.1- The registration of medicines with the same brand name and different active ingredients is not allowed, nor is the use of a brand name that has been previously used for products with different indications accepted.
6.11.2 Registration is only accepted using the same brand name, in the case of medicines declared for free sale that are used with similar therapeutic indications although they contain different active ingredients (treatment lines).
6.11.3 The registration of over-the-counter polypharmaceutical products using a therapeutic action as part of the name is accepted.
6.11.4 The use of the owner’s name or its acronym accompanied by the international non-proprietary name of the active ingredients is accepted in the name of a medicine.
6.11.5 The name of the medication, the lakes or other phrases should not have therapeutic connotations that could cause confusion in the indications for use.
6.11.6 The name of the drug to be registered must coincide with all the documentation presented, otherwise an explanatory note signed by the owner or his legal representative must be presented, duly legalized if authorized to do so, specifying that all the documents correspond to the same drug.
6.11.7 A medicine can be designated with a brand name or with an international non-proprietary name. When it is a trademark, it cannot be confused with an international non-proprietary name or mislead about the therapeutic properties or the nature of the drug.
6.12. Co-packaged drugs .
6.12.1 In the case of co-packaged medications, each medication must be registered separately and subsequently request a modification of the registration for the co-packaging.
In the event that some of the products are not registered, you must register and then request co-packaging. The expiration date granted will be that of the registration that expires first.
6.12.2 In case the commercialization of several products for a specific treatment is requested in a single package and the products are not previously registered, you must start the registration process, complying with the requirements of each product included in the package.
6.13. For the labeling of the medicines referred to in this regulation, the provisions of the current Central American Technical Regulation on the Labeling of Pharmaceutical Products for Human Use must be governed.
All information present on the label or printed on the packaging of the medication or insert, prospectus or instructions addressed to professionals or patients, must adhere to the information approved in the registry.
6.14. If the same product is manufactured in different subsidiaries or countries, a Sanitary Registry must be processed by each country or manufacturing laboratory.
NOTE: In the case of El Salvador, this provision does not apply, since alternate manufacturing is established in its registration procedure.
6.15. To guarantee the quality of medicines, the Regulatory Authorities may verify compliance with the Good Manufacturing Practices by the means they deem necessary, including inspection at the facilities of the manufacturing laboratories established inside and outside the Central American countries, applying the Regulation Central American Technician for Pharmaceutical Products Medicines for Human Use Current Good Manufacturing Practices for the Pharmaceutical Industry.
The Regulatory Authority may request the regulatory authorities of regional reference and strict regulatory authorities accredited by the WHO, verification of compliance with Good Manufacturing Practices of pharmaceutical laboratories that they have inspected.
6.16. In terms of intellectual property, the current regulations of each country will be applied .
6.17. Therapeutic equivalence studies will apply the current regulations of each country.
6.18. The administrative procedure for the processing of sanitary registration, renewal and modifications will be carried out in accordance with the internal legislation of each State Party.
6.19. Failure to comply with this regulation will give rise to the application of what is established in the sanctioning regime of each state party.
7. REQUIREMENTS FOR SANITARY REGISTRATION
The requirements for health registration are as follows:
7.1. Application signed and stamped by the Responsible Professional containing the information detailed in Annex 2 of these Regulations.
7.2. Powers of attorney that prove the legal and/or technical representation granted by the holder to the natural or legal person(s), in accordance with the legislation of each country, (original or authenticated photocopy of the document) .
7.3. WHO-type pharmaceutical product certificate, which must be presented in original or authenticated photocopy of the legalized document.
In case this type of certificate is not issued, the presentation of:
7.3.1. Certificate of Free Sale In case of presenting a certificate that guarantees two or more products, an authenticated and/or certified photocopy of the legalized document will be accepted.
7.3.2. Certificate of Good Manufacturing Practices from each of the establishments involved in the manufacture of the product, for the pharmaceutical form and specific type of product to be registered, issued by the Regulatory Authority of the country or countries where the manufacturing process is carried out. manufacture, legalized original or authenticated photocopy of the same, it must indicate that it complies with the regulations of good manufacturing practices.
7.4. Manufacturing contract or, failing that, the extract relating to the parts of the manufacturing contract, when applicable, in original or authenticated or certified photocopy of the legalized document, containing at least the following information:
a) Signed by the holder and the manufacturer jointly or separately.
b) Commitment to comply with Good Manufacturing Practices.
c) Establish the conditions of production, analysis when applicable, or any other technical management related to these.
d) It must describe the handling of raw materials, packaging material, bulk material and finished product and in the event that they are rejected .
e) Allow the contracting party to enter the contractor’s (contracted) facilities for audits.
f) Allow the entry of the contractor (contracted) to the contractor’s facilities.
g) List each of the analysis products or services that are the object of the contract.
7.5. Complete quantitative and qualitative formula of the product per dose unit. It must be submitted in original , signed and stamped by the professional responsible for the manufacturing laboratory or owner of the product.
Also declare the following:
7.5.1. All drug components must be described with their internationally accepted common or generic name and must not be presented with acronyms or abbreviations, the units must be given according to the International System ( SI). In the case of active ingredients in the form of salts, esters or others, the equivalent amount of the molecule to which the therapeutic dose refers must be declared .
7.5.2. Composition of the release system for modified release products.
7.5.3. Qualitative composition of empty capsules.
7.5.4. Qualitative composition of printing inks in capsules, dragees and coated tablets.
7.5.5. Qualitative declaration of class 2 or 3 organic solvents used in the manufacturing process.
The registration of medications that use Class I organic solvents will not be allowed.
NOTE: The organic solvents mentioned in the previous paragraph are those established in USP from the 31st edition.
7.5.6. The excesses of active ingredients used in manufacturing.
7.5.7. In the case of creams and ointments, the concentration must be expressed per gram, 100g or as a percentage. Lotions, eye drops, topical sessions and parenteral infusions must express their concentration per mL, 100 mL or as a percentage.
Said complete formula may be contemplated in the Certificate of Free Sale or in the Certificate of the WHO-type Pharmaceutical Product, which will exempt it from presenting it individually.
7.6. Product monograph.
The information included in the Monograph must be based on the official books. In case of discrepancies with such books or if the medicine is not described in them, the supporting scientific information must be presented, which will be evaluated by the Regulatory Authority.
Every monograph must correspond to the pharmaceutical form of the drug to be registered, however, it may include other presentations or concentrations as long as the one being registered is included. Which must contain the following information:
a) Internationally accepted common or generic name and concentration of the drug.
b) Pharmaceutical form.
e) Structure, chemical name of the active principle or, failing that, attach the technical sheet that declares this information.
d) Clinical pharmacology.
e) Indications.
f) Contraindications.
g) Cautions and warnings.
h) Interactions.
i) Adverse effects.
j) Dosage and administration.
k) Recommendation in case of overdose according to the toxicological profile.
l) Abuse and addiction.
m) Date of revision of the monograph.
n) List of complete bibliographical references.
o) Therapeutic category according to Anatomical Therapeutic Classification (ATC), in the updated version pharmacological subgroup.
p) Method of preparation
NOTE: When the information requested is not applicable to the characteristics of the product, it may be omitted from the monograph.
7.7. Methods of analysis validated according to the Central American Technical Regulation for the Validation of Analytical Methods for the evaluation of the quality of medicines in force, attaching the report of the corresponding validation study.
7.8. Organoleptic, physical, chemical, biological and microbiological specifications of the finished product that comply with the provisions of the current Central American Technical Regulation for Quality Verification. Medications with concentrations greater than 30% alcohol; as well as those that by their nature are antiseptic, are exempt from presenting microbiological specifications.
7.9. Labels of the container / primary, secondary packaging and insert in original or their projects, in accordance with the current Central American Technical Regulations for the Labeling of Pharmaceutical Products for Human Use.
7.10. Stability Study Report in accordance with the Central American Technical Regulations for Stability Studies of Medicines for Human Use in force.
7.11. Safety and efficacy studies. All reports of clinical studies must have been prepared in a period not exceeding 10 years or present their due justification if it is greater than this period. The reports must refer to the same medicine that is presented for its sanitary registration , in the following cases:
7.11.1 For medications whose safety and efficacy have not been documented in the official literature, they must submit:
a) Conclusive reports of the results of pre-clinical studies.
b) Conclusive reports of the results of phase I, II and III clinical studies.
NOTE: These studies will be accepted in electronic format, as long as the Regulatory Authority has free access to the information.
7.11.2 In the case of medications with previously registered chemical entities whose active ingredient corresponds to new polymorphs, isomers and those derivatives with parts linked to the chemical entity that constitutes it such as Ester, ether, salt (including a salt with hydrogen bonds or coordinated ), or other non – covalent derivatives , such as complexes, among others, and are not described in the official literature must submit conclusive reports of the results of phase I, II and III clinical studies.
7.11.3. For drugs that contain previously registered active ingredients but that have one or more of the following characteristics:
a) New fixed combinations of active ingredients.
b) New pharmaceutical form with a route of administration already registered.
e) New pharmaceutical form with a new route of administration.
d) New pharmaceutical form with a new release form.
e) New potencies or concentrations of previously registered active ingredients .
f) New potencies or concentrations of active ingredients registered with the same route of administration, pharmaceutical form and dosage.
g) New form of release with the same route of administration of a previously registered medication.
h) New routes of administration with an already registered pharmaceutical form.
The conclusive reports of the clinical studies must be presented that verify the objective or objectives set according to the aforementioned variations for the product under evaluation and that demonstrate to the Authority its quality, safety and efficacy.
7. 11.4 If when evaluating the documentation it is verified that the information presented is not conclusive, the Regulatory Authority may request complementary clinical studies. In the event that the presentation of any complementary clinical study is not scientifically appropriate, the applicant must present the justification for its assessment by the Regulatory Authority.
7.11.5 An application for which information on safety and efficacy is not submitted should be considered by the States Parties as an application for the registration of a multi-origin pharmaceutical product. The Regulatory Authorities may grant the sanitary registration to a multi-origin pharmaceutical product that:
a) It is a pharmaceutical equivalent of a product that has the following characteristics:
-That the Regulatory Authority has data on safety and efficacy.
-A sanitary registration has previously been granted in the State Party to be registered and
-That it is not protected by patents or test data;
or
b) It is a pharmaceutical product that meets the following conditions:
-That the innovative product has not been registered in the country and that the health authority considers it as an exception or in case of medical needs.
-That the applicant presents a document issued or published by a regulatory authority of any country, which demonstrates that there is an innovative product that has been authorized for marketing in that country. This document must demonstrate a favorable risk-benefit ratio of the registered product. The regulatory authority of the State Party may require that the innovative product have a minimum marketing term that demonstrates the favorable risk-benefit ratio of the product to be registered. In relation to the protection of test data, the specific national legislation established for these purposes will apply.
-That there is internationally recognized information (published in official books or by strict or reference regulatory authorities), which guarantees the safety and efficacy of the pharmaceutical product to be registered.
7.12. a) Primary standards or standardized raw materials.
b) Standards of related substances and/or degradation products, when required by the methodology.
In both cases with their respective traceability through a photocopy of the analysis certificate, except for official pharmacopoeia samples that do not have these certificates.
The Regulatory Authority will evaluate, according to health risk , the requirement to present the standards of related substances and/or degradation products.
7.13. Samples of finished product, according to harmonized quantity to carry out the analysis, according to the current Central American Technical Regulation for Verification of the Quality of Medications.
When the official laboratory does not have the technology or the installed capacity to carry out the analysis of certain drugs, the Regulatory Authority will have the power to request them from external national or foreign laboratories that have said technology, accredited by the competent entities, respecting the amount of samples that the laboratory has established. The costs of sending and analyzing the samples will be paid by the manufacturer or importer, the result of the analyzes will be recognized in the member states.
NOTE: In the case of Costa Rica, requirements 7.12 and 7.13 will be requested after the drug is registered.
7.14. A copy of the finished product.
In those medicines classified internationally as radioactive or biological weapons, the Regulatory Authority may exempt the presentation of this requirement. For medicines that require a cold chain , as well as cytotoxic and biological ones , it is accepted to present the containers without the product with the closure system with which they are going to be marketed.
NOTE: In the case of Guatemala and El Salvador, the requirement will not be requested since the analysis samples are used.
In the case of Costa Rica, the requirement for the registration process will not be requested.
7.15. Proof of payment
8 REQUIREMENTS FOR CO-PACKAGED PRODUCTS
8.1 Proof of payment
8.2 Application signed and stamped by the Responsible Professional , containing the information detailed in Annex 2 of these Regulations.
8.3 Co-packaging label project and its insert, in accordance with the current Central American Technical Regulations for the Labeling of Pharmaceutical Products for Human Use.
8.4 Scientific information that supports the treatment scheme.
9 REQUIREMENTS FOR THE RENEWAL OF THE SANITARY REGISTRY
The renewal of the registration of a medicine may be managed at least 3 months before its expiration.
Once the health registration has expired, the renewal request will not be accepted and must be processed as a new registration.
If during the 6 months following the expiration of the registration of a drug, the interested party requests that the assigned number be maintained, presenting justified cause, the Regulatory Authority will maintain the original number, however, during this period, it may not be marketed.
Renewal cannot be granted until the requested post-registration changes have been approved.
In the case of medicines that are within the categories mentioned in numeral 7.11.3 that are going to be renewed and that originally their safety and efficacy have not been documented according to the sanitary requirements described in this regulation, they must present the established requirements. in said number.
9.1 When the drug maintains the information and characteristics that have been approved during the validity of the registration, when requesting renewal it must present:
9.1.1 Proof of payment.
9.1.2 Request for health registration renewal signed and stamped by the Responsible Professional, containing the information detailed in Annex 2 of these regulations.
9.1.3 Sworn statement issued by the owner or his legal representative or by the professional responsible for the registration by power of attorney issued by the owner of the product, that the information and characteristics of the product have not changed since the last modification request filed with the Regulatory Authority .
In the event that the affidavit is issued abroad, it must be duly legalized.
9.1.4 WHO-type Pharmaceutical Product Certificate or, failing that, Certificate of Free Sale and Certificate of Good Manufacturing Practices in accordance with the provisions of numeral 7.3, and must be valid at the time of presentation.
9.1.5 Labeling of the product as it is being marketed, in original, in accordance with the Central American Technical Regulations for the Labeling of Pharmaceutical Products for Human Use in force.
NOTE: When the product has not been marketed, the art project of the printing texts of the primary and secondary packaging and insert in Spanish will be accepted, accompanied by a sworn statement from the owner of the product indicating that the product has not been marketed. .
9.1.6 Stability Study Report according to current Central American Technical Regulations, signed by the technical person in charge of the stability study as designated by the owner. This requirement applies only to products that have not submitted a long-term study in previous health registrations or renewals.
9.2 In the cases in which the medicine presents modifications in the sanitary registration and that are not known to the Regulatory Authority, they may be requested simultaneously with the renewal. In the same way, if the affidavit cannot be presented, in both cases the following requirements must be met:
9.2.1 Proof of payment.
9.2.2 Request for health registration renewal and changes not submitted, signed and stamped by the Responsible Professional.
9.2.3 WHO-type Pharmaceutical Product Certificate or, failing that, Certificate of Free Sale and Certificate of Good Manufacturing Practices in accordance with the provisions of numeral 7.3, and must be valid at the time of presentation.
9.2.4 Labeling of the product as it is being marketed, in original, in accordance with the Central American Technical Regulations for the Labeling of Pharmaceutical Products for Human Use in force.
NOTE: When the product has not been marketed, the art print project of the primary and secondary packaging and insert in Spanish will be accepted, accompanied by a sworn statement from the owner of the product indicating that the product has not been marketed.
9.2.5 Report of the Stability Study according to the current Central American Technical Regulations, signed by the technical person in charge of the stability study thus designated by the owner. This requirement applies only to products that in previous health registrations or renewals have not submitted a long-term study.
9.2.6 Quantitative and qualitative formula must be presented in accordance with the requirements established in numeral 7.5.
9.2 .7 Organoleptic, physical, chemical, biological and microbiological specifications of the finished product that comply with the provisions of the current Central American Technical Regulation for Quality Verification. Medications with concentrations greater than 30% alcohol; as well as those that by their nature are antiseptic, are exempt from presenting microbiological specifications.
9.2.8 Powers of attorney that prove the legal and/or technical representation granted by the holder to the natural or legal person(s), in accordance with the legislation of each country; in case it does not appear in the file or there are changes in the designation.
9.2.9 Manufacturing contract or, failing that, the extract relating to the parts of the manufacturing contract, when applicable, as established in number 7.4.
9.2.10 According to the requested modification , you must present the documents according to Annex 1.
10. VALIDITY OF THE SANITARY REGISTRY
The Sanitary Registry will have a validity period of 5 years counted from its granting, and may be renewed for similar periods. In cases of infractions to the norms and sanitary or regulatory laws, the Regulatory Authority will proceed to cancel it.
11. CAUSES FOR NOT GRANTING THE SANITARY REGISTRY
11.1 That there is a discrepancy between the analytical result and the documentation presented. This cause will not apply to the case of Costa Rica.
11.2 That it lacks therapeutic efficacy or safety according to the reference literature.
11.3 That the studies or investigations presented in support of the application are incomplete, or insufficient to demonstrate the quality, safety and efficacy of the product.
11.4 That the documentation presented according to: the current regulations are incomplete, incorrect or out of date.
12. CAUSES FOR CANCELLATION OF THE SANITARY REGISTRY
12.1 That the product turns out to be harmful or unsafe under normal conditions of use, following the due process according to the legislation of each country.
12.2 That it has been shown that the product is not therapeutically effective.
12.3 When it is shown that the product does not have the authorized quantitative or qualitative composition or when the quality and stability guarantees, declared in the file, are breached, following the due process according to the legislation of each country.
12.4 That it is shown that the data and information contained in the registration file are erroneous or false.
12.5 That , prior warning, the current Central American Technical Regulations for Drug Labeling continue to be breached .
12.6 That for any other justified cause constitutes a foreseeable risk to the health or safety of people.
12.7 When falsehood is verified in the sworn statement submitted for registration renewal.
12.8 When requested by the registration holder.
13. EXCEPTIONS TO THE SANITARY REGISTRY
The Regulatory Authority may authorize the importation and use of medicines without health registration in the following cases:
13.1 Donations
13.2 Officially declared national emergencies and public necessity.
13.3 Orphan drugs for the States Parties.
13.4 Drugs used in clinical studies with approved protocols
13.5 In cases of medical justification .
13.6 Samples to carry out registration procedures.
13.7 Medicines purchased through the PAHO Revolving Fund.
14. SUBSEQUENT CHANGES TO THE HEALTH REGISTRY
Any change in the information made after the sanitary registration must comply with the provisions of the Classification and Requirements (Annex 1).
15. DEROGATIONS
This Central American Technical Regulation repeals only the provisions of the requirements for Sanitary registration, renewal and modifications of medicines for human use of the internal regulations of each state party, with the exception of what is established in intellectual property and bioquivalence.
16. MONITORING AND VERIFICATION
The surveillance and verification of this Central American Technical Regulation corresponds to the Regulatory Authorities of the States Parties in accordance with their legislation.
ANNEX 1 .
(Normative)
CLASSIFICATION AND REQUIREMENTS FOR MODIFICATIONS TO THE REGISTRY
SANITARY
Table
Table
Table
Table
Table
B. Modifications that must be notified to the Regulatory Authority and do not require prior approval
Table
Table
ANNEX 2 (NORMATIVE)
INFORMATION TO BE INCLUDED IN THE SANITARY REGISTRATION APPLICATION.
1. Product data
1.1 Name of the product.
1.2 Name of the active ingredients when it contains one or two active ingredients.
1.3 Pharmaceutical form.
1.4 Route of administration.
1.5 Presentation of the product.
1.6 Proposed shelf life and storage conditions.
1.7 Therapeutic group.
1.8 Mode of sale.
1.9 Type of product (innovative, multi-origin, etc.).
1.10 Registration category (new, renewal).
1.11 Analytical methodology (pharmacopoeial and non-pharmacopoeial).
1.12 Reference standard, when applicable.
2. Details of the manufacturer and conditioner:
2.1 Name of the laboratory or laboratories involved in the manufacture.
2.2 Address, telephone, fax and email.
2.3 Manufacturing stage.
2.4 Country of manufacturing laboratory.
2.5 Sanitary License Number or Sanitary Operating Permit and expiration date (when national).
3. Data of the Product Owner:
3.1 Name.
3.2 Address, telephone, fax and email.
3.3 Country.
4. Data of the Distributor(s):
4.1 Name of the distributor(s).
4.2 Address, telephone, fax and email.
4.3 Sanitary License Number or Sanitary Operating Permit and
expiration date.
Note: For Honduras, El Salvador, these data are optional.
5. Data of the Legal Representative:
5.1 Name.
5.2 Identity document number.
5.3 Address, telephone, fax and email.
6. Responsible Professional Data:
6.1 Name.
6.2 Identity document number.
6.3 Address, telephone, fax and email.
6.4 Collegiate or Pharmaceutical Chemist Registration Number.
7. Legend that gives the application the character of a Sworn Statement.
–END OF THE TECHNICAL REGULATION-
ANNEX 2 OF RESOLUTION No. 333-2013 (COMIECO -LXVI)
MUTUAL RECOGNITION OF THE SANITARY REGISTRY OF
MEDICINES FOR HUMAN USE
AREA OF APPLICATION
The Recognition applies to all sanitary registration of medicines originating in the States Parties.
1. REQUIREMENTS
to. Proof of payment.
b. Request for registration recognition signed and stamped by the Responsible Professional and the Holder or its Legal Representative, before the Regulatory Authorities of the States Parties.
c. Power of attorney duly legalized that proves the legal or technical representation granted by the holder to the natural or legal person who permanently resides in the country where mutual recognition is requested. In the event that the Legal Representative has the power, he may grant the power to the Responsible Professional.
d. Original Pharmaceutical Product Certificate , issued by the country of origin, duly legalized, that includes the qualitative and quantitative formula, the shelf life, the approved storage conditions, the approved method of sale of the product and compliance with Good Practices of Manufacturing of the manufacturing laboratory. When two or more laboratories are involved in the manufacturing process, their identification and compliance with Good Manufacturing Practices must be included as an annex.
and. The interested party will present a copy of the complete file together with a sworn statement indicating that it is a true copy of the one presented in the country where the registration was made, in order to have the necessary information to carry out the health surveillance after the Recognition. This requirement will be presented at the time of delivery of the Recognition approval document.
2. PROCEDURE
to. Presentation of the requirements established before the Regulatory Authority.
b. The Regulatory Authority verifies the requirements presented.
c. The Regulatory Authority resolves within a term of 8 business days, issuing the respective document in accordance with Annex II.
d. In case of approval, the RM and initial code of the country that performs the recognition will be assigned and that precedes the correlative number granted by the State Party, which will be kept at the time of renewal. Said code must be included in the manner established for the health registration number in the current RTCA for Drug Labeling. The validity of the recognition will be the same as the original registration.
3. ACKNOWLEDGMENT OF REGISTRATION MODIFICATIONS
3.1 REQUIREMENTS
to. Request for the recognition of the modification of the registration signed and stamped by the Responsible Professional and the Holder or his Legal Representative, before the Regulatory Authorities of the States Parties.
b. Copy of the documentation that supports the change in accordance with Annex 1 of the RTCA Pharmaceutical Products. Drugs for Human Use. Sanitary Registry Requirements, in order to have the necessary information to carry out sanitary surveillance. This requirement will be presented at the time of delivery of the Recognition approval document .
c. Change approval document.
3.2 PROCEDURE
to. Presentation of the requirements established before the Regulatory Authority.
b. The Regulatory Authority verifies the requirements presented.
c. The Regulatory Authority resolves within a term of 8 business days, issuing the respective
document in accordance with Annex II.
d. In case of approval, the interested party delivers the supporting documentation, at the time of
receive said document.
4. RENEWAL OF THE RECOGNITION OF THE REGISTRY
4.1 REQUIREMENTS
to. Proof of payment.
b. Application for the renewal of the registration recognition signed and stamped by the Responsible Professional and the Holder or his Legal Representative, before the Regulatory Authority of the States Parties.
c. Original Pharmaceutical Product Certificate , issued by the country of origin, duly legalized, that includes the qualitative and quantitative formula, the shelf life, the approved storage conditions, the approved method of sale of the product and compliance with Good Practices of Manufacturing of the manufacturing laboratory. When two or more laboratories are involved in the manufacturing process, their identification and compliance with Good Manufacturing Practices must be included as an annex.
4.1.1 If at the time of renewal of recognition there were modifications or changes
in the original registration that have not been notified must present:
1. Recognition renewal request that includes unnotified post-registration changes
2. Change approval document.
3. Copy of the documentation that supports the change in accordance with Annex 1 of the RTCA. Pharmaceutical products. Drugs for Human Use. Sanitary Registry Requirements, in order to have the necessary information to carry out sanitary surveillance. This requirement will be presented at the time of delivery of the Recognition approval document .
4.2 PROCEDURE
to. Presentation of the requirements established before the Regulatory Authority.
b. The Regulatory Authority verifies the requirements presented.
c. The Regulatory Authority resolves within a term of 8 business days, issuing the respective document in accordance with Annex II.
d. In case of approval, the recognition number and validity granted in the renewal of the registration must be maintained.
and. The interested party submits the documentation that supports the change, at the time of receiving the renewal approval.
5. CAUSES OF NON-RECOGNITION
Recognition will not be granted to the registry when:
to. There is confusion or equality in the commercial name of a previously registered pharmaceutical product.
b. The drug contains active ingredients or combinations thereof, which do not count
with documented scientific evidence of its safety and efficacy.
c. In a formulation where chemically synthesized active ingredients are combined with natural medicinal products, and said combination is not classified as a medicine.
d. The formulation is a nutritional supplement or medicinal natural product.
and. There is an international alert that questions the safety and efficacy of the active ingredient or combinations thereof.
F. In the case of co-packaging that is not scientifically justified for the requested treatment scheme . .
g. If the method of sale approved in the registry of the country of origin differs from that of the country of recognition.
6. CAUSES OF CANCELLATION
to. That the product proves to be harmful or unsafe under normal conditions of use.
b. It has been shown with conclusive scientific evidence that the product is not therapeutically effective.
c. When it is shown that the product does not have the authorized quantitative or qualitative composition or when the quality and stability guarantees declared in the file are breached.
d. That the data and information contained in the file submitted for Mutual Recognition be proven false.
and. That prior warning, the labeling with which the product is marketed in the country of recognition is different from the labeling approved in the original registration.
F. That for any other justified cause constitutes a foreseeable risk to health or _
people safety.
g. When the Regulatory Authority that granted the original sanitary registration notifies its cancellation.
h. When the owner of the registration recognition requests it.
7. RECOGNITION OF CO-PACKAGED PRODUCTS
In case it is done. An application for recognition of co-packaged drugs must submit:
to. Proof of payment
b. Application for the recognition of co-packaging signed and stamped by the Responsible Professional and the Holder or his Legal Representative, before the Regulatory Authorities of the States Parties.
c. Pharmaceutical product certificate that includes, for each of the co-packaging products, the qualitative and quantitative formula, the shelf life, the approved storage conditions, the approved method of sale of the product and compliance with the Good Manufacturing Practices of the manufacturing laboratory. When two or more laboratories are involved in the manufacturing process, their identification and compliance with Good Manufacturing Practices must be included as an annex.
d. Co-packaging approval document issued by the Regulatory Authority of the country of original registration.
and. The interested party will present a copy of the complete file together with a sworn statement indicating that the document presented is a true copy of the one presented in the country where the registration was made, in order to have the necessary information to carry out the health surveillance after the registration. recognition. This requirement will be presented at the time of delivery of the recognition approval document.
F. Copy of the project or original packaging, approved.
8. GENERAL PROVISIONS
to. For Costa Rica, the Mutual Recognition Procedure applies to medicines that have been registered with the current harmonized regulations.
b. For CA 4 products that at the date of entry into force of this procedure have been recognized as Medications and are classified as a nutritional supplement or natural product, they will not be renewed.
c. A product may not be marketed without having notified the modifications made to the original registration.
d. For products subject to test data protection, the regulations in force in each country will apply.
and. Products that require bioequivalence studies are subject to the current regulations of each country.
F. This procedure does not apply to biological and biotechnological products.
ANNEX I
(NORMATIVE)
INFORMATION TO BE INCLUDED IN THE APPLICATION FOR RECOGNITION
1. Type of procedure.
1.1 Recognition
1.2 Renewal
1.3 Modification
1.4 Copackaging
2. Product data
2.1 Product name
2.2 Name of the active ingredient(s) with their international nonproprietary name.
2.3 Pharmaceutical form.
2.4 Route of administration.
2.5 Presentation of the product.
2.6 Approved shelf life and storage conditions.
2.7 Therapeutic group.
2.8 Sales Mode.
3. Details of the manufacturer and conditioner:
3.1 Name of the laboratory or laboratories involved in the manufacture and packaging of the product.
3.2 Address, telephone, fax and email.
3.3 Manufacturing process stage .
3.4 Country of the laboratory or laboratories involved in the manufacture and packaging of the product.
4. Data of the owner of the product:
4.1 Name.
4.2 Address, telephone, fax and email.
4.3 Country.
5. Data of the distributor(s):
5.1 Name of the distributor(s).
5.2 Address, telephone, fax and email.
5.3 Sanitary license number and expiration date.
6. Data of the legal representative:
6.1 Name.
6.2 Identity document number.
6.3 Address, telephone, fax and email.
7. Data of the natural/natural or legal person registering
7.1 Name.
7.2 Identity document number.
7.3 Address, telephone, fax and email.
8. Data of the responsible professional:
8.1 Name.
8.2 Identity document number.
8.3 Address, telephone, fax and email.
8.4 Pharmaceutical chemist collegiate or registration number.
ANNEX II
INFORMATION TO BE INCLUDED IN THE APPROVAL DOCUMENT
ISSUED BY THE REGULATORY AUTHORITY OF THE
STATES PARTIES TO THE REQUEST FOR RECOGNITION
IDENTIFICATION OF THE REGULATORY AUTHORITY APPROVING OR REJECTING THE RECOGNITION
Based on the provisions of COMIECO Resolution No. 333-13, the (Sanitary Registry. Renewal of Registry. Modifications to the Sanitary Registry , Coempaque) is recognized when
MEDICATION issued by the Regulatory Authority of: ____________________________
To the product ___________________________________________________________________
Generic name:______________________________________________________________
Route of administration: __________________________________________________________
Pharmaceutical form: ____________________________________________________________
Concentration per dosage unit: _______________________________________________
Presentation of the product: _______________________________________________________
Approved Shelf Life: ______________________________________________________________
Storage conditions _________________________________________________
Name of record holder:_____________________________________________________
Country:_________________________________________________________________________
Manufacturer Name:______Country:
Method of sale: __________________________________________________________
Recognition number and sanitary registration:________________________________________
Validity:____________________________________________________________________
Signature of the Regulatory Authority and stamp:—————
-END OF DOCUMENT-
Article 2.- Valid as of June 12, 2014.
Given in the Presidency of the Republic, on the twenty-eighth day of the month of February of the year two thousand and fourteen.