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New drug RTCA

by webdevx | Jan 19, 2022 | News Alerts | 0 comments

By: Ruth Olivares, Olga Torres.

Learn about the most relevant points of the new RTCA 11.03.59:18, which regulates
the conditions and requirements for the sanitary registration of medicines for human
use in Guatemala, El Salvador, Honduras, Costa Rica, Nicaragua, and Panama. It came
into force on January 3, 2022.

1.- 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 shall be granted,
and shall 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
shall apply.

Guatemala, El Salvador, Honduras, Costa Rica, Nicaragua and Panama are subscribers
to this RTCA. This means that Panama will no longer have separate requirements
from the other Central American countries and that Costa Rica will accept Mutual
Recognition for Medicines.

3.- If a product is manufactured by di�erent subsidiaries or countries, a Sanitary

Registration must be processed for each country. Except in the case of El Salvador,
since this country allows the �gure of the alternate manufacturer.

Regarding the Pharmaceutical Product Certi�cate, for Costa Rica, Guatemala, El

Salvador, and Honduras, a certi�cate 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 e�cacy has not been
documented in o�cial literature, and to guarantee access to medicines that have
never been registered. As an opening as a result of the Covid 19 Pandemic.

5.- The Manufacturing Contract, when applicable, should contain the following
requirements:
Signed by the holder and the manufacturer, jointly or separately.
Commitment to comply with GMP.
Establish production conditions, and analysis when applicable.
Allow access to the contractor’s facilities for audits.
List each one of the analysis services or products object of the contract.

6.- In the Quali-quantitative Formula it must be clari�ed, in the case of pigments and
colorants used in the manufacture, the code “Color Index, C.I.”, the code “Food Drug
and Cosmetic, FD&C” or equivalent.

7.- In the Product Monograph:

For Panama shall include the precautions concerning excipients that are published by
the current EMA Guideline.
For products registered by Strict Authority, listed by WHO, the holder of the
registration 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.

9.- Regarding the Safety and E�cacy Studies:

They will be accepted in electronic format, as long as 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 that demonstrates
the existence of an innovative product, which has been authorized to be marketed in
the country, proving a risk-bene�t relation of the product.

10.- Analytical standards and product samples will be requested after registration
(Post Authorization Analysis). This point is pending to be validated by the Authorities
in Guatemala.

An exception to the 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.

12.- Some modi�cations 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 Certi�cate of
Product type WHO, Quali-Quantitative Formula, Exemplary of the Finished Product
(Panama), Product Samples for Analysis, Analytical Methodology, Speci�cations,
Standards, among others.

-For the change of excipients, analytical methodology, �nished product speci�cations

and technical justi�cation of the change must also be submitted.
In several updates, it is requested to submit a document issued by the owner or the
Legal Representative that accredits the change.

3.- For the process of Mutual Recognitions:

In the case of Panama, a copy of the dossier of the country of origin must be
submitted, together with the Sworn Statement that it is a true copy of the original,
from the beginning of the Recognition procedure.

The term to resolve by the Sanitary 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 process, a copy of the renewal dossier of the
country of origin must be submitted, together with the A�davit where the holder
indicates that this is a true copy when the renewal was made.

Mutual Recognition will not be granted:

If at the time of Renewal of Mutual Recognition the applicant has not noti�ed the
Health Authority of the modi�cations of the product in the country of registration.

If the product has not demonstrated stability in climatic zone IV B, in the case of
Panama.
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 applies to renewals or modi�cations.

NUEVO-RTCA-PRODUCTOS-FARMACEUTICOS-Vigencia-Enero-2022-1 Download

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