RLD identification in EU region in view of Brexit [Regulatives / Guidelines]

posted by Ohlbe – France, 2021-09-09 22:55 (84 d 18:38 ago) – Posting: # 22563
Views: 790

Dear shahajan baig,

» I wanted to know about RLD identification & selection in EU region since we do not have any specific source like in USFDA which provides the orange book data or OGD guidance.

The reference product is defined in Directive 2001/83/EC, Article 10, 2°(a) as a medicinal product authorised under Article 6, in accordance with the provisions of Article 8. Article 8, 3°(i) states that the application dossier should include results of pharmaceutical (physico-chemical, biological or microbiological) tests, pre-clinical (toxicological and pharmacological) tests and clinical trials.

Practical translation:
- the reference product has to be authorised in the EU;
- it has to be authorised based on a full dossier. You can't use a generic as reference product.

It is quite easy to find out which product is the reference product for those authorised, say, in the past 15 years, especially if they went through the centralised procedure. If you're trying to make a generic of a very old product, you may struggle.

» Also please guide me about how Brexit impacted DCP and CP in EU union for the selection of RLD.

Very simple. You can't take the reference product from the UK market to do a BE trial for an application in the EU. See point 1.3 in this Notice to stakeholders.


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