What is an annex 15?
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.
What does batch release mean?
A batch release is a certification of a medicinal product or a drug by an authorized person. The batch release must be done before the products are introduced into free trade.
What is EU GMP?
Good manufacturing practice (GMP) describes the minimum standard that a medicines manufacturer must meet in their production processes. The European Medicines Agency (EMA) coordinates inspections to verify compliance with these standards and plays a key role in harmonising GMP activities at European Union (EU) level.
What is Annex 3bis?
Bijlage/Annexe 3bis (a.k.a 3a) is a Formal Obligation form that is a pledge of financial support for the foreigner. This form is valid for a maximum of 2 years. The foreigner, also referred to as the third-country national if he/she does not come from an EU country.
What is annex 32 Belgium?
By signing the annex 32 your guarantor declares that he/she agrees to have a joint and several liability for the following costs: your health expenses, your stay in Belgium, your studies, and your return to your home country, for at least one academic year.
What is batch release in GMP?
Batch release is just part of a set of quality control measures known as the Pharmaceutical Quality System (PQS)5, or ICH Q10. PQS details quality management and processes that will ensure pharmaceutical manufacturers and their outsourced partners comply with Good Manufacturing Practice (GMP).
What is a GMP batch?
GMP Batch means: a Batch manufactured after the Engineering Batch and after the GMP Specifications and the GMP Procedures have been agreed, that is required to be manufactured according to the GMP Procedures in all material respects, to comply with GMP Specifications and to be manufactured in accordance with GMP in all …