CMDh News – September 2014
Implementation of Commission’s Decisions after referral procedures pursuant to Article 31 of Directive 2001/83/EC of the European Parliament and Council
At its meeting in September 2014, the CMDh discussed about the implementation of Commission Decisions after referral procedures pursuant to Article 30 of Directive 2001/83/EC of the European Parliament and Council for the following medicines, for which Commission’s Decision was adopted in August 2014:
- Sandostatin and related names
- Sandostatin LAR and related names
- Seroquel/Seroquel XR and related names.
CMDh encourages marketing authorisation holders og generic medicines authorised via MRP/DCP procedures to refer to the referent MS with the aim to harmonise the product information, by reporting the type IB variation (classified as C.I.1.b), provided that all the conditions from the Commission’s Regulation (EC) No 1234/2008 have been fulfilled.
After the MRP numbers consequent to the referral procedure have been known, the CMDh will accordingly to Directive 2001/83/EC of the European Parliament and Council update the table of referral procedures and as such make publicly available on its webpages.
The report from the CMDh meeting is accessible on the CMDh/HMA webpages, or here.