5. EU Regulatory procedures for a marketing authorisation (MA)

1. EU Regulatory procedures for a marketing authorisation (MA)

1.3. Non-centralised procedures: 1. National procedure

The national procedures may be used under two circumstances:

1. Independent national procedures, strictly limited to medicines which are to be authorised and marketed in only one member state (MS).

If the medicine is intended to be marketed in more than one MS, the national procedure must be followed by a mutual recognition procedure. Alternatively, a decentralised procedure may be considered to obtain the MA in parallel in several MS.

2. For variations or extensions (additional strengths, pharmaceutical forms or routes of administration) of marketing authorisations already granted nationally (e.g., to harmonise the dossiers for subsequent use of the MRP or DCP).

MSs should ensure that the procedure for granting a MA is completed within a maximum of 210 days after the submission of a valid application. Clock stops are possible.

Legal basis:  Artl. 8, 17, Directive 2001/83/EC; for variations: Artl. 4(1), 5(1) and 6(1) of Regulation (EC) No 1084/2003.