AIFA clarifications on the submission of Marketing Authorization Transfer applications of national/MRP/DCP medicinal products
With a recently published notice, on the AIFA website, the Italian Agency divulged some clarifications/updates on the modalities of submission of a MA Transfer application for national/MRP/DCP medicinal products.
The main changes include:
- Clarifications about the necessity to submit the type IAin n. C.I.8a) variation application, for the PSMF introduction, in parallel to the MA transfer application;
- New requirements concerning the submission of a copy of the proposed texts (SmPC, Package Leaflet and Labelling) with the changes resulting from the MA transfer (clean and track changes version in electronic format), for all the authorized presentations of the concerned medicinal products.
In addition, in compliance with AIFA indications, a self-declaration of conformity of the proposed texts signed in original by the future MAH, attesting the accuracy of the texts, should be provided as well.
With reference to point 1, AIFA clarifies that, in case the former and the new MAH “belonging to the same company group or that are controlled by the same physical or legal entity are to be considered as one entity” or in case of no changes to the Summary of Pharmacovigilance System, to the EU-QPPV and in the PSMF location, the Company will have to indicate this information in the MA transfer application, providing a declaration duly signed by the future MAH.
It is recalled that the MA transfer application should be supported by the following documents:
- Cover letter in Italian (in the name of the new MAH) endowed with a duty stamp of 16,00 € – signed in original
- Proof of fee payment reporting the POL code
- Agreement between the old and the new MAH – original signatures legalized by a notary are requested. In addition, should the document be in a language other than Italian, a sworn translation into Italian is also required.
Moreover, for national registrations, the Agreement has to be registered at the Italian Registry Office.
- For MRP/DCP products: paper/electronic version of the Summary Table including all manufacturers currently approved with the relevant manufacturing steps.
- For national products: Circolare 9/97 in electronic format (CD-ROM)
- Copy of the Chamber of Commerce Company registration – version updated at the time of submission of the MA transfer application.
In addition to the submission of MA transfer application at national level, the type IAin n. C.I.8 a) variation application for the PSMF introduction and, if applicable, the type IB n. A.2 b) variation for the change in the product invented name has to be submitted and a cross-reference to the parallel submission should be included in the e-AF/cover letter: indeed, as confirmed by the AIFA Competent Office, except for the cases above reported, the MA transfer cannot be finalized/approved until the PSMF variation is submitted.
It is also pointed out that, according to the MA transfer dispositions issued by AIFA, the MAH will have to update:
- the SmPC starting from the effective date of the AIFA MA transfer approval decree
- PIL/labelling starting from the first batch produced after the effective date of the AIFA disposition.
AIFA can allow an exception to the above requirements, in case of submission of an extension request, intended to continue the commercialization of batches already produced, but not yet released, with a packaging material non updated (i.e. to release batches after the date of entry into force of the MA transfer, including a PIL and labelling reporting the details of the former MAH).
For the purpose of the above mentioned request, the following information should be provided to AIFA, in parallel to the MA transfer application submission:
- Name of the medicinal product
- European procedure number (if applicable)
- MA number assigned by AIFA
- Start date and end date of batch production;
- Number of the batches object of the extension request;
- Agreement between the old and the new MAH about the extension request – original signatures legalized by a notary are requested.
Regulatory Pharma Net is available to support companies to comply with these requirements and to provide additional information and assistance regarding the MA transfer procedures.