A transfer of Marketing Authorisation (MA transfer) is the procedure whereby a Marketing Authorisation (MA) is transferred from the currently approved Marketing Authorisation Holder (MAH) to a new MAH, which is a different legal person/entity. The need for this action may be the result of the MAH’s commercial decision to sell the Marketing Authorisation or the fact that the MAH ceases to exist as a legal entity and the MA has to be taken over by another legal entity. Sometimes also the change of the legal form of the company holding the marketing authorisation may be, in the opinion of the Polish Agency, the basis to start the procedure for changing the MAH.
However, it is worth remembering that the change of name and/or address of the Marketing Authorisation Holder is not a change of MAH, provided that relevant conditions listed in the guideline “Variations guidelines – Guidelines on the details of the various categories of variations, on the operation of the procedures laid down in Chapters II, IIa, III and IV of Commission Regulation (EC) No 1234/2008 of 24 November” are fulfilled. Such a variation should be notified as an IAIN-type variation. To find out more details on different types of variations read the article “Variation – how to successfully update your dossier”.
In order to obtain a transfer of Marketing Authorisation, MAH must submit the relevant application with attachments, including a cover letter and revised product information, as well as pay a fee. The type of documents required may vary depending on the country where the application is submitted. For the centralised procedure, all necessary information and document templates can be found on the EMA website.
By contrast, for products registered in decentralised procedures, the change of MAH is processed nationally, so the type of documents needed depends on the national requirements of each Agency. In this case it may be necessary to contact the Agency to receive information on the procedure, costs, documents necessary for the notification, requirements for the local representative in the Member State, necessity to change the sPSMF, product information and mock-ups. In Poland, the change of the Marketing Authorisation Holder is performed on the basis of Article 32 of the Act of September 6, 2001 – the Pharmaceutical Law (Journal of Laws of 2021, item 126 position 1381, as amended).
Our Experts have extensive experience in the preparation and submission of documentation required for the transfer of Marketing Authorisation in the European market. Additionally, our asset is assisting MAHs in contacting the Agencies and collecting key information on the process of changing the MAH. Pharmaceutical companies from around the world have repeatedly benefited from our support and often return to us, which undoubtedly proves the high quality of services provided by SciencePharma.
Following the newest requirements of Competent Authorities is much easier with the support of experienced and well informed team. At SciencePharma we offer both preparation and submission of application for transfer of Marketing Authorisation in Poland and other European Union countries as well as complex registration/post-registration services for medicinal products – depending on individual needs of the Marketing Authorisation Holder.
If you are interested in working with us, please do not hesitate to contact us. Our Experts will answer all your questions and doubts.