What is an annex 15?
This is a ‘full registration’. You are registered in the Belgian national register. You will first receive an ‘annex 15’ as proof that you have started your registration. After the local police officer has verified your address, you apply for your electronic residence card.
Can I travel with Annex 15?
Annex 15 is a temporary document for an administrative procedure under way in Belgium. This does not give you any right to travel in the European Union.
Can I travel outside Belgium with Annex 15?
Can EU citizens live in Belgium?
EU/EEA and Swiss citizens do not require a Belgian visa and have the right to stay in Belgium for a maximum period of three months, provided they register their presence in Belgium after arrival.
What are the EU guidelines for Good Manufacturing Practice (GMP)?
EudraLex Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use Annex 15: Qualification and Validation Legal basis for publishing the detailed guidelines: Article 47 of Directive 2001/83/EC on the Community code relating to medicinal products for human use and Article 51 of
What are the annexes of the EU GMP Guide?
EU GMP guide annexes: Supplementary requirements: Annex 6: Manufacture of medicinal gases. Traceability is the ability to retrieve the history of the manufacturing and distribution operations of a batch of a medicinal product.
Are sterilisation and aseptic processing covered by the EU GMP guidelines?
The sterilisation and aseptic processing of sterile active substances are not covered by this guideline and should be performed in accordance with GMP for medicinal products (Commission Directive 2003/94/EC as interpreted in the basic requirements for medicinal products including annex 1 of the EU GMP guideline part I).
Does the GMP guideline require new active substances to be used?
Furthermore, this is made clear in the introduction to part II of the GMP guideline. Part II of the GMP guideline does include a short section on new active substances to be used as starting materials for IMPs and these remain as recommendations with no mandatory force.