Vertaling van "manufacturer responsible for batch " (Nederlands → Frans) :

Name and address of the manufacturer responsible for batch release: Elanco Animal Health Ireland Limited Finisklin Industrial Estate Sligo Ierland
Nom et adresse du fabricant responsable de la libération des lots: Elanco Animal Health Ireland Limited Finisklin Industrial Estate Sligo Irlande

The Production & Distribution department of the FAMHP is responsible firstly for overseeing the conformity to current standards, guidelines and legal requirements for the manufacture, distribution and dispensing of medicines and health products and secondly for granting authorisations, recognitions and certificates, as well as for combating illegal practices and monitoring pharmacies.
The Production & Distribution department of the FAMHP is responsible firstly for overseeing the conformity to current standards, guidelines and legal requirements for the manufacture, distribution and dispensing of medicines and health products and secondly for granting authorisations, recognitions and certificates, as well as for combating illegal practices and monitoring pharmacies.

On the basis of these European directives, the FAMHP is thus mainly responsible for supervision of the market by following up on incidents (materiovigilance) and by inspecting manufacturers, distributors and retailers established in Belgian territory.
On the basis of these European directives, the FAMHP is thus mainly responsible for supervision of the market by following up on incidents (materiovigilance) and by inspecting manufacturers, distributors and retailers established in Belgian territory.

Unit II Unit II is responsible for: ●● The recognition of industrial pharmacists ●● The granting of authorisations for the manufacture, import, export, wholesale, distribution of medicines ●● Dealing with quality problems (RAS – Rapid
Unit II Unit II is responsible for: ●● The recognition of industrial pharmacists ●● The granting of authorisations for the manufacture, import, export, wholesale, distribution of medicines ●● Dealing with quality problems (RAS – Rapid

If a non-conforming medicine is marketed outside Belgium and the medicine manufacturer is based in Belgium, the FAMHP is responsible for alerting other medicine authorities via the RAS.
If a non-conforming medicine is marketed outside Belgium and the medicine manufacturer is based in Belgium, the FAMHP is responsible for alerting other medicine authorities via the RAS.

Menveo, which was submitted in 2008 for US regulatory approval as a new vaccine to protect against four common types of meningococcal meningitis in people age 11-55, has received a Complete Response letter from the FDA requesting additional information on the submission’s clinical and CMC (Chemistry Manufacturing and Control) sections.
Menveo, a été soumis en 2008 aux autorités sanitaires américaines en vue d’obtenir son autorisation en tant que vaccin contre quatre types communs de méningite à méningocoques chez les personnes âgées de 11 à 55 ans. Ce médicament a reçu de la FDA une «Complete Response letter» demandant des informations complémentaires sur les sections Clinique et CMC (Chemistry Manufacturing and Control) du dossier.

Novartis submitted in August 2009 answers to a Complete Response letter received earlier in the year from the FDA requesting additional information on the submission’s clinical and CMC (Chemistry Manufacturing and Control) sections.
Novartis a soumis en août 2009 des réponses à une «Complete Response letter» envoyée en début d’année par la FDA et demandant des informations complémentaires sur les sections Clinique et CMC (fabrication chimique et contrôle) du dossier.

We take responsibility for our products throughout their life cycle, from discovery through to manufacturing and use.
Chez Novartis, nous suivons nos produits tout au long de leur cycle de vie, de leur découverte à leur utilisation, sans oublier la phase de production.