Simplified supply of medicinal products subject to prescription

Following the entry into force of the revised Therapeutic Products Act (TPA) and the revised Therapeutic Products Ordinance (TPO) on 1 January 2019, pharmacists may, under certain conditions, supply medicinal products subject to prescription in the absence of a prescription

Changes in the dispensing categories of medicinal products

Medicinal products may only be placed on the market when they have been authorised by Swissmedic. Swissmedic classifies medicinal products into different categories of supply.

Dispensing categories as of 1 January 2019

A: Single dispensing requiring a medical or veterinary prescription
B: Dispensing requiring a medical or veterinary prescription
D: Supply on the advice of a specialist
E: Supply in the absence of advice of a specialist

In the context of the revised Therapeutic Products Act the legislator has decided to make better use of the available skills for supplying medicinal products. Dispensing category C (Supply on the advice of medical personnel) has therefore been eliminated while category D has been broadened.
Thus the conditions for supplying medicinal products of dispensing category B have been made more flexible and the boundaries between the categories of medicinal products (prescription-only/not subject to prescription) are now less strictly defined - without, however, adversely affecting treatment safety. Pharmacists are now able to supply certain medicinal products of dispensing category B to patients who do not have a prescription.

Supply of medicinal products, subject to prescription, by pharmacists in the absence of a prescription  

Medicinal products of the supply category B

The government’s aim was to simplify the supply by pharmacists of certain medicinal products subject to prescription. Until 1 January 2019 medicinal products authorised under dispensing category B could only be supplied by a medical professional on presentation of a medical prescription. Since 1 January 2019, however, pharmacists have been permitted to supply medicinal products of dispensing category B in the absence of a prescription in the following cases:

1. The medicinal product was classed as dispensing category C prior to 1 January 2019

As dispensing category C has been eliminated following the entry into force of the revised Therapeutic Products Act, certain medicinal products of this category have been reclassified to dispensing category B. Those medicinal products that have been transferred from dispensing category C into category B and are thus now subject to prescription may nevertheless be supplied by pharmacists in the absence of a medical prescription. The medicinal products in question are listed on the website of Swissmedic, which is responsible for the reclassification:

Reclassification of medicinal products: status update

2. Medicinal products for the treatment of common illnesses

This group includes a number of medicinal products that are used for treating common illnesses and contain established active substances that have been authorised for several years. The Federal Council, acting on the advice of a group of experts, is defining those medicinal products that may under certain conditions be supplied by pharmacists without prescription, as well as defining the indications concerned (see next paragraph). The indications, the medicinal products in question and the other modalities applicable to their supply will be published on the FOPH website as they are approved.

3. Medicinal products used to continue a long-term treatment

Medicinal products that allow the patient to continue a long-term treatment may also be dispensed by pharmacists without a prescription for up to one year after the date of the initial prescription. This applies above all to the treatment of chronic illnesses.

As previously, pharmacists may supply medicinal products subject to prescription in the absence of a medical prescription if exceptional circumstances apply.

In all the instances listed above, the medicinal products may only be supplied by the pharmacists themselves, and such supply shall be documented. In this context, the Association of Cantonal Pharmacists (ACP) proposes to draft guidelines aimed at ensuring uniform implementation in the cantons.

Medicinal products indicated for the treatment of common illnesses

A “List of indications” expert group has been mandated to advise the Federal Department of Home Affairs (FDHA) to establish the list of indications and the authorised medicinal products for the treatment of common illnesses.

Evaluation procedure

The quality of patient care and their safety when using the medicinal products are the primary criteria considered in the evaluation.

The expert group proceeds as follows to establish the list of indications and the corresponding medicinal products:

·        Formulation and continuous extension of the list of possible indications and medicinal products of supply category B which may be dispensed by pharmacists in the absence of a prescription

·        Choice of an indication for further detailed treatment:

o   Consultation of the corresponding specialised medical societies and if needed other external experts

o   Final counsel on the list of indications and medicinal products by the expert group by drawing on the recommendations of external specialists, on scientific criteria and on experience in the field

·        The list of recommended medicinal products for each indication is submitted for approval to the Federal Council/the FDHA

·        Periodic review of the list of medicinal products.

Indication of seasonal allergic rhinitis and rhinoconjunctivitis

The experts established a first list of medicinal products of category B which, in the absence of a medical prescription, may be supplied by pharmacists in cases of seasonal allergic rhinitis or rhinoconjunctivitis.
The SSAI (Swiss Society for Allergology and Immunology) and the Swiss Society of ENT (SGORL) have received the experts’ proposal for comment.
Based on the above-mentioned criteria, the expert group adopted a list of medicinal products that was then approved by the Federal Council/FDHA.

The list may be found under the following link:

The lists of medicinal products for other indications are currently being compiled and will be published on this site as soon as they have been approved by the Federal Council.

Last modification 28.03.2019

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Contact

Federal Office of Public Health FOPH
Division of Biomedicine
Therapeutic Products Law Section
Schwarzenburgstrasse 157
3003 Berne
Switzerland
Tel. +41 58 463 51 54
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