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Key Facts

France

Map of France

Reception Date

20.06.23

Category

HEALTH, MEDICAL EQUIPMENT

HEALTH, MEDICAL EQUIPMENT

Ministries & Departments

Direction des affaires juridiques

Responsible Departments

Ministères économiques et financiers

Products & Services concerned

Foods for special medical purposes (FSMPs)

Related EU Law

None

Explanation

The consumption of FSMPs carries a number of risks and can have harmful health consequences if they are improperly consumed.

Summary

Article L  5137-1 of the Public Health Code, in its wording resulting from Law No 2023-171 of 9 March 2023, now provides that FSMPs, other than those presenting a serious risk to health in the event of misuse, may be issued only by: ‘pharmacies for internal use in health establishments, army hospitals or the National Invalids’ Institution, dispensing chemists or, under conditions guaranteeing effective medical supervision, by establishments, services or service providers, the list of which shall be drawn up by the Minister for Health.’.

Notification Timeline

This timeline summarizes key events in the notification process

Law is drafted in France France notifies the draft law 20.06.23 Draft law returns to France Commenting Periode Ends 21.09.23 1 Member States & EC Responses 0 Detailed Opinions 0 Comments 1 External Stakeholders Responses

Notification Comparison

Track the evolution of this law — uncover the changes made from draft to final version based on input from the Commission, key organisations, and Member States.

Highlighted sections mark additions, and crossed-out text marks what was removed.

Document Corner
EU Flag
Originating Department: Direction des affaires juridiques
Responsible Department: Ministères économiques et financiers
Received: 2023-06-20 00:00:00
Country: France
Category: HEALTH, MEDICAL EQUIPMENT

Order establishing the list of establishments, services or service providers who may supply foods for special medical purposes in accordance with the provisions of Article L. 5137-1 of the Public Health Code

Notification No.: 2023-0379-FR

THE FRENCH REPUBLIC
Ministry for Health and Prevention
Order of […]
establishing the list of establishments, services or service providers who may supply
foods for special medical purposes in accordance with the provisions of Article L. 5137-1
of the Public Health Code
NOR: […]
Order of 15 December 2023 establishing the list of establishments, services or service providers
who may supply foods for special medical purposes in accordance with the provisions of Article
L. 5137-1 of the Public Health Code
NOR: SPRH2334630A
ELI: https://www.legifrance.gouv.fr/eli/arrete/2023/12/15/SPRH2334630A/jo/texte
Official Journal of the French Republic No 0295 of 21 December 2023
Text No 76
The Minister for Health and Prevention,
Having regard to Directive (EU) 2015/1535 of the European Parliament and of the Council of
9 September 2015 laying down a procedure for the provision of information in the field of
technical regulations and of rules on Information Society services (codification), and in
particular notification No 2023/XXX/F;
9 September 2015 laying down a procedure for the provision of information in the field of technical
regulations and of rules on Information Society services (codification);
Having regard to the Public Health Code, in particular Article L. 5137-1 thereof;
Decrees:
Having regard to notification No 2023/379/FR sent on 20 June 2023 to the European Commission;
Hereby decrees:
Article 1
Foods intended for special medical purposes other than those referred to in the second
paragraph of Article L. 5137-3 of the Public Health Code may be supplied under conditions
guaranteeing effective medical supervision:
Foods intended for special medical purposes other than those referred to in the second paragraph of
Article L. 5137-3 of the Public Health Code may be supplied under conditions guaranteeing effective
medical supervision:
1. Health cooperatives running a pharmacy for internal use;
2. Healthcare establishments which do not have a pharmacy for internal use;
3. The following medical and social institutions and services:
a) Elderly residence facilities mentioned in point 6 of I of Article L. 312-1 of the Social
Action and Family Code;
b) Residence facilities for minor or adult disabled persons mentioned in points 2 and 7 of I of
the same article;

a) Elderly residence facilities mentioned in point 6 of I of Article L. 312-1 of the Social Action and
Family Code;
b) Residence facilities for minor or adult disabled persons mentioned in points 2 and 7 of I of the
same article;
c) The facilities called: ‘healthcare beds’, ‘medicalised reception beds’ and ‘assisted-living
apartments’ mentioned in point 9 of I of the same article;
d) The experimental establishments or services referred to in point 12 of the same article;
4. The social and medico-social cooperatives referred to in Article L. 312-7 of the Social
Action and Family Code running at least one establishment or service mentioned in point 2;
5. Service providers and distributors of materials referred to in Article L. 5232-3 of the Public
Health Code.
In health establishments with a pharmacy for internal use, foods for special medical purposes
other than those referred to in the second paragraph of Article L. 5137-3 of the Public Health
Code may be supplied, in connection with the pharmacy for internal use, by a department of
the establishment.
4. The social and medico-social cooperatives referred to in Article L. 312-7 of the Social Action and
Family Code running at least one establishment or service mentioned in point 3;
5. Service providers and distributors of materials referred to in Article L. 5232-3 of the Public Health
Code;
6. The centres and structures referred to in Article L. 6325-1 of the Public Health Code.
In health establishments with a pharmacy for internal use, foods for special medical purposes other
than those referred to in the second paragraph of Article L. 5137-3 of the Public Health Code may be
supplied, in connection with the pharmacy for internal use, by a department of the establishment.
Article 2
This Order shall be published in the Official Journal of the French Republic.
Dated
The Minister for Health and Prevention,
For and on behalf of the Minister: For and on behalf of the Minister:
Dated 15 December 2023.

For and on behalf of the Minister:
The Director-General for Healthcare,
M. Daude
The Director-General for Health,
G. Emery

Download the Draft & Final Versions of the Law

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Commenting Organisations

This section lists all organisations that have submitted comments on this notification. Each entry includes the organisation’s name, the number of contributions made, and a link to view their comments. Explore the list to understand which stakeholders are actively engaging in the consultation process.
Organisation Comments Date Total Contributions
Syndicat français de la nutrition spécialisée 2023-09-19 1
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