Pharmacists of pharmacies open to the public may outsource certain types of pharmaceutical preparations to preparation authorisation holders or to title holder pharmacists at other pharmacies that are open to the public.
The conditions for outsourcing pharmaceutical preparations are described in the Royal Decree of 21 January 2009 on instructions for pharmacists (from article 33 onwards).
The outsourcing must be laid down in a cooperation agreement. The client remains responsible for, among other things, checking the validity of the preparation, labelling and delivery to the patient. The subcontractor is responsible for making the preparation, choice of packaging, establishing storage conditions and shelf life, quality checks and the quality of the preparation.
All outsourcing must be properly documented. The client shall keep a register of subcontracts. The subcontractor delivers the preparation to the client no later than the next working day and ensures the packaging is correctly labelled (serial number, storage conditions, etc.). When subcontracting substances that fall under the Royal Decree of 6 September 2017 (narcotics), a narcotics voucher is required in certain cases.
The subcontractor is obliged to set up a quality system and to check the quality of the preparations on a regular basis, including periodic checks of the preparations made by an external laboratory.
Outsourcing to a holder of a preparation authorisation
The following preparations may be outsourced to holders of a preparation authorisation:
- preparations that entail a risk for the maker;
- cephalosporins and penicillins;
- all sterile preparations;
- homeopathic medicines for human and veterinary use;
- mixtures of gases for medicinal use of varying composition and intended for testing of lung function.
The list of authorisation holders is available on our website.
Subcontracting to a title holder pharmacist in another pharmacy that is open to the public
The following preparations may be subcontracted to title holder pharmacists of other pharmacies:
- dry forms, such as capsules, granules, mixtures of powders, whether or not in unit doses;
- semi-solid preparations for cutaneous use as defined in the Therapeutic Pharmaceutical Formulary;
- solutions for internal or external use, liquid or not, other than those that must be sterile;
- sterile solutions for internal and external use;
- liquid emulsions and suspensions for internal and external use;
Pharmacists who wish to make pharmaceutical preparations on behalf of other pharmacists by outsourcing, also called subcontractors, must fill out a notification form and send it to the deputy-Prime Minister and the Minister for Social Affairs and Public Health by registered mail. Upon receipt, the FAMHP checks the notification and the subcontractor is added to the list on the FAMHP website.
The notification form is accompanied by a number of documents. These must be enclosed in the registered letter. As this concerns a large number of documents, the FAMHP also accepts the digital form.
- Submit the documents via e-mail to firstname.lastname@example.org.
- Please mention in the subject of the email the license number of your pharmacy (6 digits, the same number as on the anaesthetic vouchers) and the message "Notification of outsourced pharmaceutical preparation".
Your notification form itself must be sent by registered mail. If you send the additional documents digitally, please mention this on the notification form.