The pharmacy for internal use must be set up or transferred within one year of the date on which the authorisation is deemed to have been obtained or has been notified by any means that provides a definite date of receipt. At the end of this period, any authorisation that has remained without effect lapses. However, if justification is provided before the expiry of this period, it may be extended…
I.- 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…
The following are activities involving particular risks, mentioned in the third paragraph of the I of Article L. 5126-4, for which authorisation is granted for a period of seven years by the competent authority: 1° sterile preparations covered by 2° of the I of Article R. 5126-9; 2° preparations covered by 2° of the I of Article R. 5126-9 produced from raw materials or pharmaceutical specialities containing substances that are…
I.-The draft contract by which a pharmacy for internal use in a healthcare establishment or an army hospital entrusts the production of the preparations mentioned in Article R. 5126-22 to a pharmaceutical establishment is submitted for the opinion of the Director General of the Regional Health Agency for the location of the establishment or army hospital, by any means which ensures that it is received with a date certain. The…
The duration of the authorisation referred to in I of Article L. 5126-8 for supply and retail sales may not exceed one year.
I.-The provisions of the first paragraph of article R. 5126-27 and those of articles R. 5126-28 and R. 5126-30 relating to requests for the creation and transfer of a pharmacy are applicable to requests for the closure of an in-house pharmacy. These requests must include all evidence to show that the existence of an in-house pharmacy is no longer justified and must specify the means envisaged to meet the pharmaceutical…
For the application of II of article L. 5126-4, the authorisation may only be suspended, except in the event of an immediate danger to public health, or withdrawn once the administrative authority competent to issue the authorisation has informed, as appropriate, the natural person holding the authorisation to operate the establishment or the legal representative of the legal entity concerned of the nature of the infringements observed and has given…
The pharmacist in charge of managing the internal-use pharmacy is responsible for the tasks and activities authorised for that pharmacy. The staff assigned to the pharmacy perform their duties under the technical authority of the pharmacist in charge of managing the internal-use pharmacy and the assistant pharmacists of that internal-use pharmacy. The pharmacist in charge of managing the pharmacy for internal use directs and, in liaison with the other pharmacists,…
The time spent by the pharmacist in charge of managing an in-house pharmacy in an establishment may not be less than the equivalent of five half-days per week. However, in medico-social establishments, this attendance time may be reduced to the equivalent of two half-days per week, taking into account the needs of the people cared for.
Whatever the cause and duration of his absence, the pharmacist responsible for managing the pharmacy for internal use shall be replaced under the conditions defined by the statutory provisions applicable to him or by the contract binding him to the employer. The replacement pharmacist is subject to the same service obligations as the pharmacist he is replacing. The replacement is carried out by a pharmacist who fulfils the conditions of…
Our French business lawyers are here to help.
We offer a FREE evaluation of your case.
Call us at +33 (0) 1 84 88 31 00 or send us an email.
is a Registered Trademark of
PETROFF LAW FIRM (SELARL LEGASTRAT)
182, rue de Rivoli
75001, Paris France
RCS Paris n°814433470
Paris Bar Registration n° (Toque) C2396
is a Registered Trademark of
PETROFF LAW FIRM (SELARL LEGASTRAT)
182, rue de Rivoli
75001, Paris France
RCS Paris n°814433470
Paris Bar Registration n° (Toque) C2396
Resources
is a Registered Trademark of
PETROFF LAW FIRM (SELARL LEGASTRAT)
182, rue de Rivoli
75001, Paris France
RCS Paris n°814433470
Paris Bar Registration n° (Toque) C2396
Useful links
Our French business lawyers are here to help.
We offer a FREE evaluation of your case.
Call +33 (0) 1 84 88 31 00 or send us an email.
All information exchanged through this website will be communicated to lawyers registered with a French Bar and will remain confidential.
