French Public Health Code
In forceI.- Pursuant to the second paragraph of I of Article L. 5126-4, any changes to the information contained in the authorisation referred to in Article R. 5126-28 that do not fall within the scope of II must be declared in advance to the Director General of the Regional Health Agency with territorial jurisdiction by the natural or legal person holding the authorisation referred to in Article R. 5126-28. This declaration shall be sent by any means that provides a date certain of its receipt.
The declaration shall be accompanied by a file containing, among the information listed in Article R. 5126-27, the elements enabling the Director General of the Regional Health Agency to assess the nature and importance of the change or changes requested.
The Director General of the Regional Health Agency has a period of two months from the date of receipt of the declaration accompanied by a complete file in which to make known his reasoned opposition to all or part of the modifications envisaged by any means giving a certain date to the receipt of the information.
In the event of an incomplete file, he may request any additional information relating to the modification declared and necessary for the examination of the declaration. The two-month period is then suspended until this information is received.
At the end of the two-month period, in the absence of any reasoned objection from the Director General of the Regional Health Agency, the planned modification(s) are deemed to have been authorised.
II.Substantial changes to the initial authorisation referred to in the second paragraph of I of Article L. 5126-4 are subject to authorisation by the Director General of the Regional Health Agency with territorial jurisdiction.
The following changes are considered to be substantial:
1° The performance of a new task among those referred to in 1° of I of Article L. 5126-1 or of a new activity among those mentioned in 1° and 2° of article L. 5126-6 or in I of article R. 5126-9;
2° The performance of a new task or a new activity by the internal-use pharmacy on behalf of another internal-use pharmacy within the framework of the cooperative ventures provided for in II of article L. 5126-1 or Article L. 5126-2;
3. Modification of the premises allocated to an activity mentioned in Article R. 5126-33;
4. the pharmacy for internal use serving a new site for the establishment, service, organisation or group to which it belongs.
The application must be accompanied by a file containing, amongst the information listed in Article R. 5126-27, the information required to assess the nature and importance of the change or changes requested.
The decision to authorise or the reasoned decision to refuse the change is issued in accordance with the procedure set out in I of Article R. 5126-28 and in Article R. 5126-30.
The decision to authorise mentions the changed and authorised elements set out in II of Article R. 5126-28.
III. - The prior declaration set out in I or the decision to refuse the change is issued in accordance with the procedure set out in I of Article R. 5126-28 and in Article R. 5126-30.The prior declaration provided for in I or the request for authorisation to modify provided for in II is sent by the head of the organisation concerned to the Minister for Defence in the case of army hospitals and to the Minister for Veterans in the case of the Institution nationale des Invalides.
The reasoned objection to all or part of the modification provided for in I or the decision to authorise or the reasoned decision to refuse the modification provided for in II is issued under the conditions provided for in II of article R. 5126-29.
