French Public Health Code
In forceI.-The authorisation to carry out preparations which may present a risk to health mentioned in the second paragraph of article L. 5125-1-1 is requested by the pharmacist holding the dispensary concerned from the Director General of the regional health agency with territorial jurisdiction.
Where the application is submitted by a company or by several pharmacists in joint ownership, it is signed by each partner or joint owner practising in the pharmacy.
The application must be accompanied by a file containing :
1° A photocopy of the current year's professional card;
2° A list of the pharmaceutical forms envisaged and the category or categories of preparations listed in the Order of the Minister for Health referred to in article L. 5125-1-1 ;
3° A plan of the pharmacy premises where the preparations are to be made, indicating the different areas and their surface areas;
4° The number and qualifications of the staff assigned to carry out the preparations;
5° The materials, equipment and preparation facilities;
6° A description of the computerised systems dedicated to this activity;
7° An information leaflet describing the general organisation, resources and procedures implemented to comply with the good preparation practices referred to in Article L. 5125-1 ;
8° A quantitative assessment of the number of preparations made or planned by pharmaceutical form.
II - Authorisation to carry out preparations that may present a risk to health is granted following an investigation by a Regional Health Agency inspector mentioned in Article L. 5127-1. This authorisation is subject to compliance with the good preparation practices mentioned in Article L. 5121-5. The authorisation decision indicates the pharmaceutical forms and the categories of preparations for which authorisation is granted, in accordance with the Order of the Minister for Health referred to in Article L. 5125-1-1.
III - Failure to reply within four months of receipt of the full application will be deemed to constitute tacit authorisation for the activity in question.
The Director General of the Regional Health Agency may request additional information from the applicant in order to examine the application. In this case, the time limit laid down in the first paragraph is suspended until this information has been received.
IV - Any change to the information mentioned in 2°, 3°, 4° and 5° of I must be declared to the Director General of the Regional Health Agency. Compliance with this formality dispenses with the need to make the declaration to the Director General of the Regional Health Agency provided for in Article R. 5125-11.
V.-Withdrawal or suspension, in whole or in part, of the authorisation to carry out preparations that may present a risk to health may be ordered by the Director General of the Regional Health Agency, where it has been established, following an investigation by a Regional Health Agency inspector referred to in Article L. 5127-1, that the pharmacy no longer complies with good preparation practices, does not comply with the scope of the authorisation or carries out preparations under conditions that endanger public health.
The decision to withdraw or suspend the authorisation to carry out preparations that may present a risk to health may only be taken after the proprietor or manager of the pharmacy has been given formal notice to submit his observations within a period of one month on the facts likely to justify the decision.
In urgent cases, the Director General of the Regional Health Agency may, without prior procedure, suspend the authorisation for a period of no more than one month.
The decision to withdraw or suspend authorisation is notified by registered letter with acknowledgement of receipt.
VI -An annual quantitative assessment of preparations that may present a risk to health, classified by pharmaceutical form and by category, is carried out by the holder of the authorisation to carry out this type of preparation by 31 March of the following year at the latest. It is forwarded to the Director General of the Regional Health Agency at his request.
If it is not sent, the authorisation may be withdrawn under the conditions set out in V.
VII-The authorisation to carry out the subcontracting activity mentioned in the second paragraph of Article L. 5125-1 for preparations presenting a risk to health constitutes an authorisation to carry out this type of preparation under Article L. 5125-1-1.
