Europe - Guidelines and Procedures for variations
- Jeremy Jakob
- Mar 8, 2023
- 2 min read
Updated: Apr 7, 2023
Here is a list of variation guidance published by EMA and commented for easiness of understanding
Current EU Variations Regulation
NEW Regulation 712/2012/EC amending Regulation 1234/2008/EC
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure:
Previous Classification guideline:
Official Guidelines published
Classification of the variations
FAQ:
1. Definition of the implementation date:
· Not defined on purpose by the European Commission and Health Authorities.
· It should be a case by case decision taking all aspects into consideration. Lies within the responsibility of the QP.
Potential
· Prospective Implementation date for Type 1A
2. Tightening of specification limits for medicinal products subject to Official Batch Release:
'Official Batch Release' means when batches have to be released to the market by a Competent Authority (CA). It is a special procedure for high risk products such as some vaccines and blood products
Procedures for the variations
Q&As:
CMDh Recommendation for classification of unforeseen variations (article 5)
As it is is regularly extended as further decisions are requested/made, it is better to use the link above.
If a proposed change doesn't fit clearly into one of the designated EU categories - it is recommended to check the Article 5 (CMDh recommendations) list, to be found on the CMDh website. Judgements can be assumed to be acceptable to EMA too unless indicated otherwise, even though there is no formal statement to this effect.
• If it's not here either - be very cautious not to inappropriately squeeze something into an existing Type IA classification, if it doesn't fit well. Better to go with a IB unforeseen than to risk a non-compliance situation when the Agency judges an already-implemented change to be a IB.
• If there remains any level of doubt and a residual compliance risk, ensure you have buy-in on your decision from your representative, and at the same time you can explore the possibility of checking with the Agency upfront.
• Finally - consider if you want to - and have time to - submit an Article 5 request yourselves.
CMDh Example for acceptable and not acceptable groupings for MRP/DCP products
Worksharing
Template letter of intent work sharing procedure
Points to consider:
• need for early approach: please note that you should send the request notification of a Worksharing Procedure 3-6 months prior to intended submission.
• Clones are not considered to be the same MA. Therefore any submission including a product with clones, higher than Type IAs (Type IBs and Type IIs) requires a worksharing procedure
o for CP no need to send a letter of intent for worksharing when it affects a product and its clones, an email to inform agency about the upcoming worksharing submission should be sent instead at least one months prior to submission.
• Cost: possibility to save submission fees
Example of a transfer of a MA from one company to another legal entity.
The transfer of a MA from one Company to another legal entity is not classified in the variation regulation. This should be considered as an administrative change and it is a purely national submission.
According to the Q6A document on variations:
"the transfer of the MA to a new MAH is to be handled as an independent purely national application"
コメント