French Public Health Code
In forceI.-In order to carry out one or more of the activities provided for in 1° to 10° below, the internal-use pharmacy must have an authorisation expressly mentioning this or these activities or issued tacitly following an application expressly mentioning this or these activities:
1° The preparation of doses to be administered of medicinal products mentioned in article L. 4211-1 or experimental or ancillary medicinal products defined in article L. 5121-1-1;
2° The preparation of magistral preparations from raw materials or proprietary medicinal products;
3° The preparation of hospital preparations from raw materials or proprietary medicinal products;
4° Reconstitution of proprietary medicinal products, including reconstitution of advanced therapy medicinal products as defined in Article 2 of Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004, and reconstitution of investigational advanced therapy medicinal products;
5° Putting into appropriate form, with a view to their administration, advanced therapy medicinal products prepared on an ad hoc basis, including experimental medicinal products, in accordance with the package leaflet or protocol for research involving the human person;
6° Preparing radiopharmaceutical medicinal products;
7° Preparing experimental medicinal products, with the exception of advanced therapy medicinal products and advanced therapy medicinal products prepared on an ad hoc basis, and carrying out preparations made necessary by the research involving the human person mentioned in Article L. 5126-7;
8° The importation of investigational medicinal products;
9° The importation of preparations from a Member State of the European Union or party to the Agreement on the European Economic Area or from Switzerland, prepared in accordance with standards of good practice at least equivalent to those provided for in article L. 5121-5 by establishments duly authorised under the legislation of the State concerned;
10° The preparation of sterile medical devices under the conditions set out in Article L. 6111-2.
For the preparation and importation of the investigational medicinal products referred to in 7° and 8°, the internal-use pharmacy is subject to the provisions of Articles R. 5124-57-1 to R. 5124-57-6.
II.-The internal-use pharmacy may, within the framework of the cooperation provided for in II of article L. 5126-1 or that provided for in article L. 5126-2, be authorised to carry out one or more of the tasks provided for in I of article L. 5126-1 or the activities provided for in I of this article.
When the agreement referred to in I of article L. 5126-10 is entered into with a pharmacist responsible for managing an internal-use pharmacy, the latter must be authorised to carry out the tasks and activities on its own behalf.
An internal-use pharmacy may be authorised to supply only other internal-use pharmacies in the same establishment or establishments which are members, associates or members of the same grouping within the meaning of Article L. 5126-2.
III. - The internal-use pharmacy which carries out the tasks and activities provided for in I of Article L. 5126-1 must be authorised to carry out the tasks and activities provided for in I of this Article.An internal-use pharmacy which carries out the activities referred to in 2, 3 or 4 of I of this article may be authorised to carry out the task provided for in 3 of Article L. 5126-6.
The internal-use pharmacy which carries out the activity mentioned in 10° of the I of this article may be authorised to carry out the task provided for in 1° of article L. 5126-5.
