A marketing authorisation (MA) can be granted for a medicinal product once its efficacy, safety and quality can be shown to be at an acceptable level. The legal basis for the application is determined by the type of the product, for example, whether the medicine is an originator product or a generic product. Also the documents required in the MA application depend on the legal basis of the product. For products with a totally new active pharmaceutical ingredient (API), determining the legal basis is quite simple – in such cases, a full or complete application containing the documents required under Article 8 of Directive 2001/83/EC is needed. For other kinds of products, an application based on well-established medicinal use or an abridged application can be an option.
From the point of view of regulatory procedure, there are different ways to apply for an MA in the EU. If the MA applicant wishes to get an MA only in one EU country, the national procedure may be the best choice. After the national MA has been granted in one EU country, it can be recognised in other EU countries based on the first MA. This procedure is called the mutual recognition procedure (MRP). In the decentralised procedure (DCP), a new MA is simultaneously applied for in several EU countries. In the centralised procedure (CP), an MA is simultaneously applied for all EU countries by submitting the application for a scientific assessment to the European Medicines Agency EMA. It is good to remember that the CP procedure is always mandatory for certain types of medicines.
The legal basis for an MA application and the different MA application procedures are determined and described in the legislation at EU level and thus applicable in all EU countries.
Efficient regulatory affairs services across the EU countries – from a single service provider with a wide partner network
In the EU, the harmonised pharmaceutical regulatory framework offers a range of significant benefits as the standards and processes across all EU member states are consistent and predictable. With the help of these harmonised regulations and our efficient remote collaboration tools, language skills and hand-picked professional partner network, we at Medfiles can serve our clients in any EU country.
We can help our clients with their MA application strategy, document requirements, writing and compilation of the application and coordinating the MA application process with the authorities, regardless of the target countries. Different EU countries do have some national requirements and specialities, however, Medfiles can cover those with the help of our international high-quality partner network. While the core strategy and coordination are managed from Finland, the execution of local tasks is entrusted to our network. This way, our clients benefit from the best of both worlds: a centralised point of contact for strategy and oversight, coupled with the local expertise of our selected partners.
Companies manufacturing medicines face different kinds of changes, for example in the supply of starting materials, analytical methods, manufacturing processes, sites and artwork management. Management of changes in a GMP environment requires time and diverse expertise. One part of change management is to assess whether the change will give cause to a variation in the marketing authorisation. Medfiles has years of experience in assessing changes from the regulatory point of view, and our CMC and regulatory affairs experts can support your work with change controls and prepare and submit variation applications for all EU countries.
If you need support or an extra pair of hands for headquarter-level regulatory affairs work in the EU or local expertise in Finland, Estonia, Latvia or Lithuania, our experienced pharma regulatory experts are here to help you!
Author: Anna Alonen, Head of Operations, Pharma Regulatory Strategy
Anna Alonen joined Medfiles in 2014. As the leader of a team of marketing authorisation experts, Anna’s responsibilities encompass new marketing authorisation applications and regulatory strategies. Anna and her team are experienced in working with regulations, and Medfiles’ marketing authorisation experts have helped clients to plan regulatory strategies, successfully compiled marketing authorisation applications and coordinated application procedures.
Anna’s journey at Medfiles began as a marketing authorisation expert, a position in which she honed her skills and knowledge of the field. Armed with a Ph.D. in pharmaceutical chemistry, acquired during her tenure at the University of Helsinki, Anna brings with her a strong, academic educational background. Her past engagements at the Finnish Medicines Agency and Pharma Industry Finland have further enriched her expertise, equipping her with valuable insights into the broader pharmaceutical landscape. Anna’s wide-ranging skill set covers research, expert consultancy, team management and project leadership.
Global pharma company & Medfiles: Cooperation in obtaining and maintaining marketing authorisations in the EU
“Medfiles has been a valuable partner for us during the registration and maintenance of products in Europe. They consistently provide prompt and accurate responses whenever there are inquiries or concerns related to European approvals.”
This is how a client from outside the EU, who has been working with Medfiles for 7 years, describes the partnership. The company initiated cooperation with Medfiles when they required assistance in entering the European market. The cooperation has involved applying for new marketing authorisations as well as managing products post-approval.
Free Guide: WHAT YOU NEED TO KNOW ABOUT ACTIVE SUBSTANCE REGISTRATION STRATEGY?
Drug substance quality must be demonstrated in the marketing authorisation application, and in Europe, there are three different ways to do this. The choice depends mainly on the API in question. The easiest way is to go with CEP whenever possible.
We have created a guide on the basic information you need to know about registration, so that you can make the best choices for your project.
