- For all procedures, portuguese is mandatory for the letter of access, for the renewal format and for the SPC and literature.
- For MRP and DCP, literature in portuguese should only be sent at the end of the procedures, by e-mail.
3. Content for national procedures:
1. Together with the cover letter and a comprehensive table of content the marketing authorisation holder submits a renewal application with the following annexes:
1.1.Part IA amended, if applicable.
1.2.Proof of payment of fee.
1.3.A list of all authorized product presentations for which renewal is sought in tabular format.
1.4.Details on contact persons:
·Qualified person in EEA for Pharmacovigilance and the QP for Pharmacovigilance in Portugal
·Contact person in with overall responsibility for product defects and recalls
·The name and contact details of a contact person at the address of the marketing authorisation holder (if different from the address of the contact person during the procedure)
1.5.List of EU Member States / Norway / Iceland / Liechtenstein where the product is on the market and indicating for each country which presentations are marketed and the launch date;
1.6. Chronological list of all post authorisation submissions (variations, extensions etc.), follow-up measures and, for Community Authorisations only, any Specific Obligations submitted since grant of marketing authorisation or last renewal indicating scope, status, date of submission and date when issue has been resolved;
1.7.Revised list of all remaining follow-up measures and specific obligations and signed letter of commitment (where applicable);
2.The currently authorised SPC and proposed texts for SPC, labelling and package leaflet to take account of issues raised by the expert. All changes must be clearly highlighted. (EN and relevant national translations);
3.Periodic Safety Update Report (PSUR) and Summary Bridging Report on safety, if applicable.
6.Quality expert statement including Currently authorised specifications for the active substance and the finished product and qualitative and quantitative composition in terms of the active substance(s) and the excipient(s).
7.A statement, or when available, a certificate of GMP compliance, not more than three years old, for the manufacturer(s) of the medicinal product listed in the application issued by an EEA competent authority or MRA partner authority.
8.In addition for manufacturing sites of the medicinal product not located in the EEA or in the territory of an MRA partner, a list of the most recent GMP inspections carried out by other authorities indicating the date, inspection team and outcome.
9.In accordance with legislation manufacturing authorisation holders are required to use as starting materials only active substances which have been manufactured in accordance with the detailed guidelines on good manufacturing practice for starting materials as adopted by the Community. The following declarations are required:
i. A declaration by the Qualified Person (QP) of each of the manufacturing authorisation holders (i.e. located in the EEA) listed in the application form where the active substance(s) is used as a starting material, that the active substance(s) is manufactured in accordance with the guidelines on good manufacturing practice for starting materials as adopted by the Community.
ii. Where different, a declaration by the Qualified Person (QP) of the manufacturing authorisation holder(s) listed in the application form as responsible for batch release, that the active substance(s) is manufactured in accordance with the guidelines on good manufacturing practice for starting materials as adopted by the Community.
. 2 CD-Rom - with the complete information including the “Renewal format “in portuguese.
or, the following paper copies:
. Complete application (original) x 2 + Renewal form, in portuguese x 2