The term “referral” is commonly used, which is a literal translation of the English word “referral”. In fact, the term ‘Community arbitration’ should be used.
However, whatever the term used, it refers to two findings:
- there is a divergence of opinion between Member States concerning the procedure for the authorisation of a new medicinal product or a medicinal product already authorised in the European Union;
- it is necessary to refer this dispute to a European authority for expertise (CVMP and EMA) and the decision
Applications for interim measures for Community interest (Article 82)
End of the different types of interim measures (Articles 33, 34, 35 and 78 currently of Dir 2001/82), only interim measures for Community interest (Article 82) remain, as well as a review procedure in the event of disagreement at the end of the procedure RM, DCP repeat-use or amendment requiring an evaluation (Article 54).
The EMA will have to publish the new referrals on its website.
The CVMP will have 120 days to prepare an opinion. This period may be extended to 180 days depending on the comments of the MA holders concerned. They may be asked to provide explanations, so the deadline may be suspended. At the end of this period, the EMA forwards the final opinion + the evaluation report with the conclusions to the MS, the EC and the MA holders.
Within 15 days, the holder(s) may request a re-examination of the notice. He then has 60 days to submit the detailed reasons for the re-examination request. Then the CVMP has 60 days to re-examine its opinion.
Once the EC opinion has been sent to the MS, the latter have 30 days to comply with it by requesting, where appropriate, the holder to file an MA application with assessment. Veterinary medicinal products authorised under the national MA procedure which have been subject to an interim procedure under Article 82 must be transferred to the mutual recognition procedure.
Article 54 review
In a decentralised procedure, mutual recognition, subsequent recognition (repeat) or modification requiring an assessment, where MS do not reach an agreement, the re-examination procedure in accordance with Article 54 shall apply.
The MS which has objections shall forward them to the other MS, to the applicant/MA holder. The Reference Member State (RMS) has 90 days from receipt of objections to refer the matter to the CMDv and reach an agreement. The applicant/MA holder shall have the opportunity to make known his/her views orally or in writing.
If an agreement is reached, the SMR closes the procedure and the MA is granted or amended. Similarly, if there is consensus to refuse the MA or reject the amendment, the SMR closes the procedure and the MA is rejected or the amendment is rejected.
If the SMR fails to reach an agreement, the CMDv must provide the EC with the assessment report and the reasons for disagreement at the end of the 90-day period. The EC then has 30 days to prepare its draft decision. This 30-day period may be suspended if the EC requests clarifications from MS or EMA. At the end of the 30 days, the EC must adopt a decision which may be: granting/refusal/withdrawal/amendment of the MA or rejection of the amendment.
DCP and centralised
The Regulation also introduced the possibility for the applicant to request a re-examination of the RMS assessment report (Article 50) as in the centralised procedure (Article 45). However, there is no provision for the applicant to present his or her views orally or in writing during these proceedings. CMDv has published a new best practice guide for the application of Article 50: BPG Re-examination.