In the course of the new pharmacovigilance package, marketing authorisation holders in the EU will be confronted with a range of new requirements. One of these requirements relates to the submission of detailed information on medicinal products - generally - on the authorisation status and on the marketing authorisation holder. The background to this catalogue of requirements is the provisions laid down in Article 57(2) of the new Regulation (EU) No 1235/2010. According to that regulation, the EMA requires these data to create a database indexing all authorised medicinal products for human use. Article 57(2) says:
"For the purposes of the database, the Agency shall set up and maintain a list of all medicinal products for human use authorised in the Union. To this effect the following measures shall be taken:
(a) the Agency shall, by 2 July 2011 at the latest, make public a format for the electronic submission of information on medicinal products for human use;
(b) marketing authorisation holders shall, by 2 July 2012 at the latest, electronically submit to the Agency information on all medicinal products for human use authorised or registered in the Union, using the format referred to in point (a);
(c) from the date set out in point (b), marketing authorisation holders shall inform the Agency of any new or varied marketing authorisations
granted in the Union, using the format referred to in point (a)".
In a "Legal Notice on the Implementation of Article 57(2), second subparagraph of Regulation (EC) No. 726/2004" published on 5 March 2012 the EMA details the required information. The requirement of the document's last version - according to which detailed information on the APIs of a medicinal product must be provided - has been deleted. The list of data to submit still remains extensive and includes among other things the following points:
- Information about the marketing authorisation holder
- Marketing authorisation status
- Data about therapeutic indications
- Details of the qualitative and quantitative composition of the medicinal product (including excipients)
- Information on the use of the medicinal product
According to the provisions of Article 57(2) the EMA is obliged to publish electronic samples for the transmission of information. 9 further documents gathered in a collection section entitled "Detailed guidance on electronic submission of information on medicinal products" as well as 2 Q&A documents were also published on 5 March together with the Legal Notice.
These publications provide precise indications on how to submit the data to the EMA.
For companies concerned, the schedule is pretty tight. Indeed, the requirements are already applicable as from 2 July 2012.
You can find the 11 documents on electronic submission of information on the EMA website.
Dr Gerhard Becker
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)