In Europe, Marketing Authorisation Applications (MAAs) can be submitted following different procedures. If Marketing Authorisation Holders (MAHs) desire access to all member of the European Economic Area (EEA) using a single procedure, the Centralised Procedure (CP) is the way to go. The EEA includes the members of the European Union plus Norway, Iceland and Lichtenstein. For applications on a country by country basis the National Procedure (NP) would be appropriate, the most common procedure also used worldwide. In Europe though there are two additional procedures in place to accommodate specific EEA requirements: the Mutual Recognition Procedure (MRP) and the Decentralised Procedure (DCP). Both procedures try to eliminate costly approval for medicinal products that are already approved in another member state.
The MRP procedure should be used where a medicinal product has already received a Marketing Application (MA) in a Member State (MS) at the time of application.
The DCP procedure should be used where a medicinal product has not yet received a MA in a MS at the time of application.
Both MRP and DCP are procedures to obtain MAs in more than one MS. It is open for all applications not falling under mandatory scope of the Centralised Procedure. One of the most important aspects for both MRP and DCP is that for both procedures, MS’s rely on each other’s scientific assessment.
But now there seems to be a new kid on the block, the Subsequent Recognition Procedure (SRP) supporting veterinary marketing applications.
When can it be used?
The Subsequent Recognition Procedure may be used after completion of a first Mutual Recognition Procedure or a Decentralised Procedure for the recognition of a Marketing Authorisation by additional Member States for the same veterinary medicinal product. The SRP can be used in MS’s, which were not included in the original MA or in Concerned Member States (CMS) where the MA was withdrawn.
At the end of a successful SRP, the “new” CMS will either recognise the MA of the product with the same SPC, labelling and package leaflet that were approved in the earlier MRP or DCP, or a new variation will be introduced in the “old” CMS to implement any requested changes linked to Potential Serious Risk (PSR) concerns. Minor editorial changes can be submitted with the first variation after the closing of the procedure.
Is the SRP really new?
In short: No. The SRP could also be referred to as the Repeat-Use Procedure (RUP), which was the common term previously used before implementation of Regulation 2019/06/EC.
What is required?
According to the Council of the European Union, Proposal for a Regulation of the European Parliament and of the Council on veterinary medicinal products, dated 08/June/2018, the following administrative information referred to in Article 7(1)(a) should be submitted
- Applicant such as name and address of manufacturing sites;
- Identification of the veterinary medicinal product such as product name and substance;
- Product information such as summary of product characteristics (SmPC) and proposed text for packaging;
- Other information such as list of countries the MA has been authorised in.
For the SRP, additional information is required:
a) A list of all decisions granted, suspending or revoking MAs concerning this veterinary medicinal product;
b) Information on the variations introduced since the MA by DCP (Article 46(5)) or MRP(Article 48(5a)) was granted;
c) A summary report on pharmacovigilance data.
With SRP, are we introducing another submission type for veterinary medicinal products? Not quite as the Repeat Use Procedure was covering most of the aspects of SRP. There are however a few areas to notice such as outlined in Article 48a of the “Proposal for a Regulation of the European Parliament and of the Council on veterinary medicinal products”. One aspect of interest is the handling of the MA in case of disagreement between respective member states. More another time.