By: Ruth Olivares, Olga Torres.
The applied changes will be effective as of January 3, 2022.
- The objective of RTCA 11.03.59:18 is to establish the conditions and requirements under which the sanitary registration of medicines for human use could be granted, and apply to all medicines for human use imported or manufactured in the territory of the subscribing countries, except for nutritional and food supplements, homeopathic products, radiopharmaceuticals, biological and biotechnological products, as well as orphan drugs, in which cases the local legislation of each State will be applied.
Guatemala, El Salvador, Honduras, Costa Rica, Nicaragua and Panama are subscribers to this RTCA. Wich means that Panama will no longer need to separate requirements from the other Central American countries and that Costa Rica will accept Mutual Recognition for Medicines.
- If a product is manufactured by different subsidiaries or countries, a Sanitary Registration must be processed for each country. Except in the case of El Salvador, since this country allows the figure of the alternate manufacturer.
- Regarding the Pharmaceutical Product Certificate, for Costa Rica, Guatemala, El Salvador, and Honduras, a certificate issued by a Strict Regulatory Authority that approves the product will be accepted, even though it is not the country of origin of the holder, in the case of products whose safety and efficacy has not been documented in official literature, and to guarantee access to medicines that have never been registered before. As an opening in the wake of the Covid 19 pandemic.
- The Contract Manufacturing Agreement, when applicable, should contain the following requirements:
⦁ Signed by the holder and the manufacturer, jointly or separately.
⦁ GMP compliance commitment.
⦁ Establish production conditions, and analysis when applicable.
⦁ Allow entry to the contractor’s facilities for audits.
⦁ List each of the analysis services or products subject to the contract. - In the Qualitative Formula, clarify, in the case of pigments and colorants used in manufacturing, the code “Color Index, C.I.”, the code “Food Drug and Cosmetic, FD&C” or equivalent.
- In the Product Monograph:
⦁ For Panama should include the precautions concerning excipients that are published by the current EMA Guideline.
⦁ For products registered by Strict Authority, listed by WHO, the registrant may opt for the monograph published by such authority. - Regarding the Stability Study, Panama will apply only climatic zone IV b, for long-term studies under controlled conditions.
- Regarding the Safety and Efficacy Studies:
⦁ They will be accepted in electronic format, provided that the Regulatory Authority has free access to such information.
⦁ The Regulatory Authority may request complimentary studies if the information submitted is not conclusive.
⦁ Registration may be granted even if these Studies have not been submitted when the product is innovative and has not been registered in the country, provided that the health authority considers it as an exception or medical necessity.
⦁ The above would also apply if the applicant submits a document demonstrating the existence of an innovative product, which has been authorized to be marketed in the country, accrediting a risk-benefit relationship of the product.
- Analytical standards and product samples will be requested after registration (Post Authorization Analysis). This point is pending validation by the Authorities in Guatemala.
- An exception to obtaining sanitary registration is considered for those medicines negotiated through the Council of Ministers of Health of Central America (COMISCA). Honduras is exempted in this case.
- Some modifications are made to the procedures for Post Registration Changes, among which it is worth mentioning:
-The addition of primary and secondary packers does not apply to Nicaragua and Panama.
- Requirements are added for the change of origin or manufacture by third parties (Change of Manufacturer and/or Change of Country of Origin), including Certificate of Product type WHO, Qualitative and Quantitative Formula, Exemplary of the Finished Product (Panama), Product Samples for Analysis, Analytical Methodology, Specifications, Standards, among others.
- For the change of excipients, analytical methodology, finished product specifications and technical justification of the change must be also submitted.
- In several updates, it is requested to submit a document issued by the owner or the Legal Representative that accredits the change.
- For the procedure of Mutual Recognitions:
⦁ In the case of Panama, a copy of the dossier of the country of origin must be submitted, together with the Affidavit that the same is a true copy of the original, from the beginning of the Recognition procedure.
⦁ The term to resolve by the Health Authority is extended to 10 working days, instead of 8 days. In the case of Panama it will be 30 working days.
⦁ For the Mutual Recognition Renewal procedure, a copy of the renewal dossier of the country of origin must be submitted, together with the Affidavit where the holder indicates that this is a true copy when the renewal was made.
⦁ Mutual Recognition will not be granted:
(a) If at the time of Renewal of Mutual Recognition the applicant has not notified the Health Authority of the modifications of the product in the country of registration.
b) If the product has not demonstrated stability in climatic zone IV B, in the case of Panama.
c) Non-compliance with GMP according to the RTCA.
⦁ Mutual Recognition does not apply to products excluded from the RTCA.
⦁ In the case of El Salvador, for products with an alternate manufacturer authorized in the same registration, the holder must process separate Mutual Recognitions for each of the Manufacturers. The same shall apply for renewals or modifications.
In due time, it will be informed if there are additional requirements or application forms for each country.