Paragraph 1: Application for marketing authorisation or registration

Articles in this section · 2

D5141-55D5141-55-1

Article D5141-55

French Public Health CodeIn force
Ask for lawyer reviewed or certified translation

Updated 1 Nov 2023

I.-The amounts of the fee provided for in 1° of 1 of I of Article L. 5141-8 for marketing authorisation applications under a national procedure, a mutual recognition procedure or a decentralised procedure for which France acts as the reference Member State are set as follows:

1° €25,000 for an application relating to :

a) A veterinary medicinal product which is the subject of a complete dossier referred to in Article 8 of Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC;

b) A veterinary medicinal product containing a new combination of substances and which is the subject of a dossier referred to in Article 20 of Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC;

c) A veterinary medicinal product containing active substances with a well-established use and which is the subject of the dossier mentioned in Article 22 of Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/ EC.

The amount is set at €5,000 for a jointly submitted application concerning a veterinary medicinal product containing the same active substances and referring to the same studies.

2° €20,000 for an application relating to:

a) A generic veterinary medicinal product which is the subject of the dossier referred to in Article 18 of Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC;

b) A hybrid veterinary medicinal product which is the subject of the dossier referred to in Article 19 of Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC.

The amount is set at €5,000 for a jointly submitted application concerning a veterinary medicinal product containing the same active substances and referring to the same studies.

3° €5,000 for an application relating to :

a) A veterinary medicinal product, submitted with the consent of the holder of the marketing authorisation for the original veterinary medicinal product and which is the subject of the dossier referred to in Article 21 of Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC ;

b) A veterinary medicinal product intended for a limited market and which is the subject of the dossier referred to in Article 23 of Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC;

c) A veterinary medicinal product, presented in exceptional circumstances and which is the subject of the dossier referred to in Article 25 of Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC.

II.-The amounts of the fee provided for in 1° of 1 of I of Article L. 5141-8 for marketing authorisation applications under a mutual recognition procedure or a decentralised procedure for which France acts as the Member State concerned are set as follows:

1° €12,000 for an application relating to :

a) A veterinary medicinal product which is the subject of a complete dossier referred to in Article 8 of Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC;

b) A veterinary medicinal product containing a new combination of substances and which is the subject of a dossier referred to in Article 20 of Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC;

c) A veterinary medicinal product containing active substances with a well-established use and which is the subject of the dossier mentioned in Article 22 of Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/ EC.

The amount is set at €3,000 for a jointly submitted application concerning a veterinary medicinal product containing the same active substances and referring to the same studies.

2° €7,500 for an application relating to:

a) A generic veterinary medicinal product which is the subject of the dossier referred to in Article 18 of Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC;

b) A hybrid veterinary medicinal product which is the subject of the dossier referred to in Article 19 of Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC.

The amount is set at €3,000 for a jointly submitted application concerning a veterinary medicinal product containing the same active substances and referring to the same studies.

3° €5,000 for an application relating to :

a) A veterinary medicinal product, submitted with the consent of the holder of the marketing authorisation for the original veterinary medicinal product and which is the subject of the dossier referred to in Article 21 of Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC ;

b) A veterinary medicinal product intended for a limited market and covered by the dossier referred to in Article 23 of Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/ EC;

c) A veterinary medicinal product, presented in exceptional circumstances and covered by the dossier referred to in Article 25 of Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/ EC.

The amount is set at €3,000 for a jointly submitted application concerning a veterinary medicinal product containing the same active substances and referring to the same studies.

III. The amount of the fee provided for in 1° of 1 of I of article L. 5141-8 is set at €1,500 for an application for the transfer of a marketing authorisation for a veterinary medicinal product.

IV. The amount levied for an application mentioned in III covering several medicinal products may not exceed €50,000.

Mariela Petrova

Need help applying this article to your situation?

A registered French Lawyer explains what applies to your business — in English, fixed fee.

within 48h

Fixed Fee

Talk to a lawyer
Previous articleArticle D5141-58Next articleArticle D5141-55-1
Common Questions

Working with a corporate lawyer in France — Q&A

Any time a strategic decision changes how the company is owned, governed or contractually bound — incorporation, fundraising, M&A, restructuring, shareholder agreements, or major commercial contracts. Earlier engagement always costs less than later remediation.

A notary (notaire) is a public officer who authenticates specific deeds (mainly real-estate transfers and certain family-law acts). A corporate lawyer (avocat) advises on strategy, negotiates and drafts company documents, and represents you in disputes. The two roles complement rather than overlap.

Yes — most of our clients are foreign suppliers, investors or holding entities. We bridge the gap between French law and your home jurisdiction's expectations and deliver everything bilingually.

The SAS (Société par Actions Simplifiée) is the default choice for most international structures: flexible governance, single shareholder allowed, no minimum capital, and works cleanly with foreign holding entities. We assess SARL, SA, SCI on the merits when the situation calls for it.

Yes — communications with a French avocat are protected by the secret professionnel (Article 66-5 of the Law of 31 December 1971). This protection is broader than the common-law attorney-client privilege and applies to written and oral exchanges.

We work on fixed fees for clearly scoped engagements (incorporation, contract drafting, audits) and on monthly retainers for ongoing advisory. Hourly billing is the exception, not the default. You always know the cost before work starts.

Typical timeline is 2–3 weeks from KYC kick-off to RCS registration, assuming standard documentation. Holding-company structures, foreign-shareholder identification or in-kind contributions can extend this — we flag the gating items at the first meeting.

Absolutely. We routinely coordinate with your in-house counsel, expert-comptable or notaire — pragmatic collaboration is the norm, not the exception. We send them everything they need to do their part without duplicating work.

Mariela Petrova

Mariela Petrova

Avocate au Barreau de Paris

Toque #C2396

15+ Years In Corporate Practice

English · French · Russian

Ready When You Are

Talk To A Corporate
Lawyer In France.

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.

Talk To A Corporate Lawyer+33 1 84 88 31 00
First EngagementFixed Fee

Talk to a French lawyer.

Reply within 24 hours.

Communications protected by professional secrecy — secret professionnel de l'avocat, Article 66-5 of the Law of 31 December 1971.

Continue Reading

Related corporate services in France

01 / Setup

Setting up a French company

Choose between SAS, SARL, SA or SCI — and structure your first French entity around how you actually plan to operate.

Read More
02 / Operating

French commercial contracts

Distribution, agency, supply, services and IP licences — drafted around the protections French law actually gives.

Read More
03 / Disputes

Business disputes & litigation

Shareholder conflicts, commercial breaches and pre-litigation strategy — handled by the same team that knows the file.

Read More