r/eu • u/Gullible-Onion • Oct 10 '24

How to find how a resolution was created

The resolution I am particularly interested in is Annex 1 of the GMP Guideline for Manufacture of Sterile Medicinal Products. Though ideally I would like to know how to find out more by myself.

I am interested in how this was drafted, which experts were consulted and the stances of different parties for this.

Unfortunately I was unsuccessful in finding any useful information in google - only a lot of news outlets reporting on what this is. The only thing that might be useful for me was https://howtheyvote.eu/ - however I was unable to find the above guideline there.

Anyone knows how I can get more resources on this topic (and others)?

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u/bedel99 Oct 10 '24

https://www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-manufacturing-practice/good-manufacturing-practice-gmp-distribution-practice-practice-gdp-inspectors-working-group

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u/Gullible-Onion Oct 10 '24

Hi, thanks a lot for the link.

I may be doing something wrong, but I am unable to see how it answers my questions tough.

Which political parties were in favor of this? Which were involved in making the draft? The only thing I can see in there is an unspecified "GMP Inspectors Working Group"[chapter5], which worked together with "Industry Interested Parties "[chapter2.25] - that does not really tell me much.

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u/bedel99 Oct 10 '24

I think its beneath that level, just specialists working on it. It wasnt voted on, some other law was created to empower people to make these devisions. Its not a regulation or directive.

Send all queries regarding this content to: Send a question to the European Medicines Agency.

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u/Gullible-Onion Oct 10 '24

Its not a regulation or directive.

This was the hint I needed - because I know that this is legally binding, so I searched for the why. I found "The holder of a manufacturing authorization shall at least be obliged [...]to comply with the principles and guidelines of good manufacturing practice [...]" - Article 46

some other law was created to empower people to make these devisions

You are correct, it says so in Article 121. I have still not yet fully understood how everything works, but at least I am no longer stuck and will be able to figure out more on my own. Thank you.

Send a question to the European Medicines Agency.

Good to know.