exploitant
English translation: Licensed pharmaceutical establishment / exploitant
| GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW) | ||||||
|---|---|---|---|---|---|---|
|
| 14:35 Mar 6, 2020 |
| French to English translations [PRO] Medical - Medical (general) / document on pharmacovigilance | |||||||
|---|---|---|---|---|---|---|---|
|
| ||||||
|  Selected response from: Florence Kermet (X) Australia Local time: 08:54 | ||||||
Grading comment
| |||||||
| Summary of answers provided | ||||
|---|---|---|---|---|
| 4 | distributor // distributing company |
| ||
| 4 | Licensed pharmaceutical establishment / exploitant |
| ||
| 1 +1 | Marketing Authorisation Holder (MAH) |
|
| Summary of reference entries provided | |||
|---|---|---|---|
| Operator/distributor/marketer |
|
Answers
33 mins confidence: 
peer agreement (net): +1
peer agreement (net): +1Marketing Authorisation Holder (MAH) Explanation: Marketing Authorisation Holder (MAH) "The Marketing Authorisation Holder (MAH) is under no obligation in terms of pharmacovigilance in France". sources: European Medicines Agency pre-authorisation procedural ... www.ema.europa.eu › documents › regulatory-procedural-guideline › e...PDF Feb 6, 2020 - The Marketing Authorisation Holder (MAH) is the person who holds ... There has been some confusion with regard to terms such as 'exploitant', ... France - The Life Sciences Law Review - Edition 7 - TLR - The ... thelawreviews.co.uk › edition › france Apr 1, 2019 - The exploitant must either be the marketing authorisation holder, a third party appointed by the latter, or both. He or she must carry out the ... Medicinal product regulation and product liability in France ... uk.practicallaw.thomsonreuters.com › ... May 1, 2018 - Only authorised pharmaceutical companies (exploitant) are allowed to ... Failure by the marketing authorisation holder/operator (exploitant) to ... The Life Sciences Law Review - Hogan Lovells www.hoganlovells.com › media › hogan-lovells › pdf › publication a marketing authorisation in France. The exploitant can be the marketing authorisation holder ('MAH') or an entity to whom such holder licenses the marketing ... Marketing Authorisation Holder - EUPATI www.eupati.eu › Glossary Nov 9, 2016 - The marketing authorisation allows the holder to market a specific medicinal product, in one or more EU member states. Once a medicinal ... -------------------------------------------------- Note added at 35 mins (2020-03-06 15:10:46 GMT) -------------------------------------------------- Marketing Authorisation Holders, Named Distributors ... - Gov.uk www.gov.uk › ... › Wildlife, animals, biodiversity and ecosystems Dec 19, 2016 - What is a Marketing Authorisation Holder. A veterinary medicinal product may not be placed on the UK market unless it is subject of a valid ... |
| |
| Login to enter a peer comment (or grade) | ||
4 hrs confidence:
distributor // distributing company Explanation: yes, essentially it's a drugs company if you will, but not necessarily the producer |
| |
| Login to enter a peer comment (or grade) | ||
3 days 17 hrs confidence:
Licensed pharmaceutical establishment / exploitant Explanation: "exploitant" is a specific status in France: this person needs to have a pharmaceutical establishment license, they should have a qualified person, called a responsible pharmacist, and the exploitant is accountable for distribution and marketing of the medicinal product onto the French market, for medical information, and for pharmacovigilance. So whenever a foreign company wants to get onto the French market they have to have this exploitant on the ground, as well as a local qualified person for pharmacovigilance. https://www.pharmavoice.com/article/2016-10-france/ Pharmaceutical establishment (p.4) :https://www.ansm.sante.fr/var/ansm_site/storage/original/app... Because it is a French status, you could also choose to leave it in the source language just like they did in the first link. https://www.codes-et-lois.fr/code-de-la-sante-publique/toc-p... -------------------------------------------------- Note added at 3 days 17 hrs (2020-03-10 08:09:43 GMT) -------------------------------------------------- "Exploitant, l'entreprise ou l'organisme se livrant à l'exploitation de médicaments autres que des médicaments expérimentaux, de générateurs, trousses et précurseurs mentionnés au 3° de l'article L. 4211-1. L'exploitation comprend les opérations de vente en gros ou de cession à titre gratuit, de publicité, d'information, de pharmacovigilance, de suivi des lots et, s'il y a lieu, de leur retrait ainsi que, le cas échéant, les opérations de stockage correspondantes." (Source: Code de la Sante Publique). According to the Code de la Santé Publique above, the "exploitant" is responsible of pharmacovigilance though. For this reason, more context from the source text in English might be needed. |
| ||
Grading comment
| |||
Notes to answerer
| |||
| Login to enter a peer comment (or grade) | |||
Reference comments
5 mins peer agreement (net): +1 |
| Reference: Operator/distributor/marketer Reference information: We've had this question several times before, and debated it at great length. For example, http://www.proz.com/kudoz/french-to-english/medical-pharmace... -------------------------------------------------- Note added at 15 mins (2020-03-06 14:50:39 GMT) -------------------------------------------------- There aren't a couple, there are lots, and I don't see any point in going over this again. But it definitely doesn't mean user in this context. |
| ||
Note to reference poster
| |||
| Login to enter a peer comment (or grade) | |||
Login or register (free and only takes a few minutes) to participate in this question.
You will also have access to many other tools and opportunities designed for those who have language-related jobs (or are passionate about them). Participation is free and the site has a strict confidentiality policy.
KudoZ™ translation help
The KudoZ network provides a framework for translators and others to assist each other with translations or explanations of terms and short phrases.
See also:
Search millions of term translations