Adaptation of fixed texts for medicinal products that may continue to be dispensed by pharmacies without a medical prescription after expert advice.
Fixed texts for medicinal products which are being reallocated from dispensing category C to B as of 2019
As part of the revision of the Therapeutic Products Act, dispensing category C was discontinued as of 2019. To make it clear that the medicinal products reallocated from dispensing category C to dispensing category B can continue to be dispensed by pharmacies without a medical prescription (but after consultation with a pharmacist), the patient information must be adapted as follows.
- Section 1 (“Information for patients”):
“…This medicine has either been prescribed for you personally by your doctor, or you have obtained it without a medical prescription from a pharmacist. Always use this medicine exactly as described in this leaflet or as instructed by the doctor or pharmacist in order to obtain the greatest benefit…..”
- Section 3 (“What … is and what it is used for”):
No fixed text required, as for non-prescription medicinal products
- Section 8 (“How to take/use …?”):
“…Keep to the dosage stated in the package leaflet or prescribed by your doctor. If you believe that the effect of the medicine is too weak or too strong, talk to your doctor or pharmacist.”
- Section 13 (“Where can you get …? What packs are available?”):
“In pharmacies without a medical prescription, after consultation with a pharmacist.”
The adaptation of the texts was directly approved as part of the reclassification procedure and will be taken into consideration in the next revision of the Ordinance of the Swiss Agency for Therapeutic Products on the Licensing Requirements for Therapeutic Products (TPLRO; SR 812.212.22).
Note: A corresponding adaptation of the fixed texts is also permissible for the medicinal products published in Annex 2 of the Therapeutic Products Ordinance (TPO; SR 812.212.21) and which may also be dispensed without a medical prescription on the basis of Art. 45 para. 1 letter a of the TPO. However, this is only the case where the whole medicinal product may be dispensed without a medical prescription, not just certain dosages or indications.
The corresponding adaptations may be implemented on the manufacturer’s own initiative without the need to submit a variation application. Important: only the above-mentioned fixed texts may be used.