By: Gabriela Solís
The National Authority of Sanitary Regulation (ANRS) of Nicaragua, establishes the guidelines for type C modifications to the registration of pharmaceutical products that require prior approval.
- Type C1 modifications are changes that require prior approval by the regulatory authority for their implementation. It should be noted that they are not regulated in the Central American Technical Regulation 11:03.59:18 (RTCA) and must comply with the requirements of the state party.
- It is allowed to request several simultaneous changes in the same procedure.
- To make the change, the product must have a valid sanitary registration and the applicant must submit the technical and/or legal documentation supporting the change, as applicable.
- For updates, it is required to submit a document issued by the holder or the Legal Representative, signed and stamped in original, that certifies the change.
We share examples of the most common type C modifications we make at LatinAlliance:
- Update of information and design in the insert, without modifying the pharmacological information contained in the monograph.
- Change in the dimension of the primary packaging.
- Updating to bilingual insert.
- Exclusion and inclusion of insert.
- Inclusion of a new blister holder.
- Updating of import, distribution, and commercialization powers, as well as of legal representative and responsible professional, when changes of owner, company name and professional are made.
- Change in the denomination of an excipient in the quail-quantitative formula.
- Change in the manufacturer of the solvent
The National Health Regulatory Authority has established requirements for change request C
Application form signed and stamped by the responsible professional.
Request letter stating the change C issued by the holder signed and sealed.
Supporting documents of the change to be requested.
It is important to clarify that the documentation to be submitted will also depend on the type of change requested by the holder.
All those changes that are not named in the Central American Technical Regulation 11:03.59:18 (RTCA), in Annex 1, type A and B modifications; however, the holder laboratory wishes to notify the regulatory authority may be notified by means of type C updates.
If you need any advice, please contact our team of professionals in Life Sciences-Regulatory Affairs through the communication channels indicated in our platforms.