Article R5121-37-3
After a marketing authorisation has been granted, the Director General of the Agence nationale de sécurité du médicament et des produits de santé may require the marketing authorisation holder to carr…
20+ full codes, 2,400+ articles translated and updated. Case law linked to every article. Read the actual text before you ask a lawyer about it — free, no login required.
20+
french codes
Fully translated
2,400+
articles in English
Updated regularly
480+
court rulings linked
Per article
Free
full access
No login required
Showing 7981–7990 of 17809 articles for “Art. 758-5”
After a marketing authorisation has been granted, the Director General of the Agence nationale de sécurité du médicament et des produits de santé may require the marketing authorisation holder to carr…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé may require samples and mock-ups to be submitted when the medicinal product is marketed.
The specific obligations which may be imposed pursuant to the third paragraph of Article L. 5121-9 and which must be mentioned in the risk management system are, in particular, the following: 1° The a…
The marketing authorisation is renewable on application by the holder to the National Agency for the Safety of Medicines and Health Products no later than nine months before its expiry date. The appli…
In the case of blood-derived medicinal products, the Agence nationale de sécurité du médicament et des produits de santé may, when examining the application for marketing authorisation, submit samples…
The Minister for Health may, on a proposal from the Director General of the National Agency for the Safety of Medicines and Health Products, require by order that companies exploiting certain immunolo…
During the examination of marketing authorisation applications, the Director General of the Agence nationale de sécurité du médicament et des produits de santé may order any investigative measure he d…
When, on the occasion of the implementation of Article 20(4) of Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004, urgent action is essential to protect human…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé will make a decision within two hundred and ten days of the submission of a complete application file. W…
The marketing authorisation issued by the Agence nationale de sécurité du médicament et des produits de santé lapses if it transpires that: 1° That it is not followed by the marketing of the medicinal…
Avocate au Barreau de Paris
Toque #C2396
15+ Years In French Corporate Practice
English · French · Russian
Ready When You Are
A 20–30 minute call, in English, to scope the engagement. No obligation, no preliminary fee. You will leave the call with a clear view of what the work will cover and what it will cost.
20+ full codes and 2,400+ articles in English, with the key court rulings linked to every article — free to read.
Read MoreA lawyer-reviewed report explaining how the relevant articles apply to your situation, with case-law analysis and next steps.
Read MoreScope your matter with a Paris-Bar avocate — incorporation, contracts, disputes — handled bilingually, end to end.
Read More