#SSAS2211446AOrder of April 12, 2022, listing drug classes eligible for hybrid groups registry
AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.
This law identifies specific classes of medications that can be included in the French hybrid groups registry. It focuses on drugs used for obstructive respiratory diseases, particularly those used in inhalation therapies. This affects pharmaceutical companies involved in producing these medications, requiring them to consider this classification for drug submissions.
AI-generated summary. May contain errors. Refer to official sources for legal decisions.
Key Changes
- Introduction of specific ATC classes into the hybrid groups registry
- Focus on inhalation medications for obstructive respiratory diseases
Obligations
What this law requires
Pharmaceutical companies must ensure medications in ATC class R03A (adrenergic inhalation drugs for obstructive respiratory diseases) are eligible for inclusion in the French hybrid groups registry when submitting for classification
Pharmaceutical companies must ensure medications in ATC class R03B (other inhalation medications for obstructive respiratory diseases) are eligible for inclusion in the French hybrid groups registry when submitting for classification
The Director General of Health (Directeur général de la santé) must execute this order within their respective scope of responsibility
The Director of Social Security (Directeur de la sécurité sociale) must execute this order within their respective scope of responsibility
The Director General of the National Agency for Medication Safety and Health Products (ANSM) must execute this order within their respective scope of responsibility