French Public Health Code
In forceI.- Authorisation to carry out the subcontracting activity referred to in the second paragraph of article L. 5125-1 is requested by the pharmacist owning the pharmacy from the Director General of the regional health agency with territorial jurisdiction.
When 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 is accompanied by a file containing the information mentioned in 1° to 8° of the I of article R. 5125-33-1.
II - The authorisation to carry out the subcontracting activity is issued following an investigation by an inspector from the Regional Health Agency referred to 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 mentions the pharmaceutical forms and, where applicable, the categories of preparations mentioned in 2° of I of Article R. 5125-33-1 for which authorisation is granted.
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 of this III is suspended until this information has been received.
IV - Any change to the information mentioned in 2°, 3°, 4° and 5° of I of Article R. 5125-33-1 must be declared to the Director General of the Regional Health Agency. Compliance with this formality dispenses with the need to make the declaration provided for in article R. 5125-11.
V.-Withdrawal or suspension, in whole or in part, of the authorisation to carry out the activity of subcontracting 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 mentioned 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 the preparations under conditions that are dangerous to public health.
The decision to withdraw or suspend the authorisation to carry out the subcontracting activity 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.
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 shall be notified by registered letter with acknowledgement of receipt.
VI-The written subcontracting contract referred to in the second paragraph of Article L. 5125-1 is drawn up in accordance with the good preparation practices referred to in Article L. 5121-5.
VII -An annual statement of subcontracting contracts indicating the details of the contractors, the number of preparations subcontracted, the pharmaceutical forms of the preparations subcontracted, the active substances they contain and, where applicable, the categories of preparations for which authorisation has been granted is drawn up by the holder of the authorisation to carry out the subcontracting activity 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.
