Authorisation of a medicinal product according to Art. 14 para. 1 abis of the Therapeutic Products Act (TPA, SR 812.21) requires submission of documentation on pharmacological, toxicological and clinical studies according to Art. 4 and 5 of the Therapeutic Products Licensing Requirements Ordinance (TPLRO, SR 812.212.22) or Art. 8 and 11 TPLRO for veterinary medicinal products. This may be submitted in bibliographic form if sufficient proof of the safety and efficacy of the medicinal product is available in the published specialist literature. Based on accumulated experience, Swissmedic will now accept submission on the basis of study reports or EU dossiers instead of bibliographic documentation.
Irrespective of which documentation the application is based on, the evidence submitted by the applicant must be summarised in a scientifically sound way and, for example evaluated critically by means of expert statements. For human medicinal products, this may also be in the form of a non-clinical / clinical overview (Module 2.4 / 2.5), or an expert report or detailed and critical summaries (DACS) for veterinary medicinal products.
In principle, Swissmedic does not check and approve any information for healthcare professionals when authorising a medicinal product according to Art. 14 para. 1 aquater. However, the information for healthcare professionals can now also be prepared at the applicant's discretion if this is beneficial for the safe use of the medicinal product.
Furthermore, in all procedures according to Art. 14 para. 1 letter abis-quater TPA for human medicinal products, the dosage recommendation must take into account the requirements of the Guidance document Medicinal product information for human medicinal products HMV4 (section on “Requirements for specific medicinal product groups and procedures”). The dosage recommendation must be feasible with the medicinal products authorised in Switzerland. If further medicinal products are required in order to implement the dosage recommendation, a corresponding note must be added to the product information.
There have also been some changes to wording and some further explanations have been added regarding the content, but these do not involve any new requirements for the applicant.
The new version of the guidance document takes effect on 1 September 2021.