Section 4: Fees levied in connection with operations carried out by the agency

Articles in this section · 2

D5321-7D5321-8

Article D5321-7

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

Updated 1 Nov 2023

The amount of the duty provided for in Article

L. 5321-3

is set as follows:

1° Under 1° of I :

For the analysis of samples and the assessment of the documentation relating to the control protocol submitted by the manufacturer, with a view to the release of batches of immunological medicinal products mentioned in 6° of Article L. 5121-1 : €3,500.

For the assessment of the documentation relating to the control protocol sent by the manufacturer, with a view to the release of batches of immunological medicinal products mentioned in 6° of article L. 5121-1: €500.

For the analysis of samples and the assessment of the documentation relating to the control protocol sent by the manufacturer, with a view to the release of batches:

- of blood-derived medicinal products mentioned in article L. 5121-3 : €950;

- of plasma mixtures intended for the manufacture of blood-derived medicinal products: €100;

- of substances which, if used separately from a medical device in which they are incorporated as an integral part, are likely to be considered as blood-derived medicinal products: €950.

2° Under 2° of I:

For the performance of an inspection expressly requested by an establishment carrying out the activities mentioned in article L. 5138-4 in order to verify compliance with the good practices mentioned in article L. 5138-3 and to issue, where applicable, the certificate attesting to such compliance, the amount of the fee is made up of a flat-rate portion of €1,000 and a variable portion calculated per day of site inspection up to a limit of €9,000 according to the following scale:

- when the inspected establishment is located in a Member State of the European Union or in a State party to the Agreement on the European Economic Area: €300 per day;

- when the inspected establishment is located in any other State: €3,000 per day.

3° Under 3° of I:

For the supply of reference substances from the French Pharmacopoeia: €45 per substance supplied.

4° Under 4° of I:

For the issue of quality certificates to exporters of medicinal products: €3,000 per batch.

Those liable for the duty relating to the operations mentioned in 1°, 2°, 3° or 4° above shall pay it to the departments mentioned on the collection order issued by the Ministry of Health.

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 R5321-6Next articleArticle D5321-8
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