Owing to the revision of the TPA and the corresponding implementing ordinances (Therapeutic Products Ordinance Package IV), Swissmedic has adapted the specification documents and forms for authorisation applications.
With the ordinary revision of the TPA (Stage 2, TPA2), the legislator aims to improve the public access to medicines and the general environment for biomedical research and industry. The Federal Council referred the Dispatch on the Revision of the Therapeutic Products Act to Parliament on 7 November 2012. The National Council and Council of States adopted the core elements of the Federal Council's draft, with certain changes, and approved the revised Therapeutic Products Act in the final vote on 18 March 2016.
Because of the numerous amendments to the Act, the relevant ordinances also need to be comprehensively amended. Individual provisions (national recommendations on dosages of paediatric medicinal products, definitive arrangements for medicinal products approved by cantons) and the corresponding ordinance terms already entered into force at the beginning of 2018. The Medicinal Products Licensing Ordinance (MPLO) is being revised in the context of the drafting of the provisions for implementing the Medicrime Convention.
A consultation procedure for the remaining implementing provisions (Therapeutic Products Ordinance Package IV) was carried out from 21 June to 20 October 2017. This work affects ordinances issued both by the Federal Council and the Agency Council of Swissmedic. Feedback from the consultation procedure is currently being assessed.
According to the current schedule, the revised Act and the ordinances – with the exception of the Ordinance on Integrity and Transparency for Therapeutic Products – should enter into force on 1 January 2019.
The latest revision of the Act and the newly proposed amendments to the implementing regulations are aligned to the following aims:
Facilitating market access
Create new, simplified authorisation options for certain medicinal product categories (especially medicinal products authorised in an EU or EFTA country, medicinal products with traditional uses, medicinal products already approved in a canton, as well as various medicinal products used in complementary medicine)
simplify self-medication by modifying the allocation of the medicinal products to the different supply categories, and ease the supply requirements.
Improving drug safety
Tighten up and modernise market surveillance (introduce the pharmacovigilance plan, apply Good Vigilance Practice, increase the scope and define the reporting obligations in more detail)
improve the safety of medicinal products used in paediatrics (publish a directory for off-label dosage recommendations for the medicinal products used in paediatrics, establish new obligations and incentives for the pharmaceutical industry to promote the development of paediatric medicinal products)
define minimum requirements for the prescription of medicinal products.
Increase the scope of information published about the medicinal products submitted to Swissmedic for assessment and their authorisation holders (particularly publication of the assessment reports for human medicinal products with new active substances on which the authorisation decisions are based [SwissPAR])
clarify the arrangements regarding pecuniary benefits (integrity and transparency) and strengthen the implementation of these provisions as well as the obligation to pass on discounts in accordance with health insurance legislation
create an information system for monitoring the distribution and use of antibiotics and the antibiotic resistance situation in veterinary medicine.
Dates & events
Go-live/publication of new specification documents
Swiss Public Assessment Report (SwissPAR) and Public Summary SwissPAR: publication, receipt of application and authorisation decisions
Full declaration, new templates for patient information and information for healthcare professionals, black triangle, Italian information for healthcare professionals, publication of product information
Redesign of forms, Internet lists
Revision of the Medicinal Products Licensing Ordinance (MPLO): introduction in law
Revision of MPLO, part 1: definitions, licence types, requirements for RP
New establishment licences, new GMP/GDP certificates
Revision of MPLO, part 2: individual import licences, special licences, compassionate use
Congress Centre Kursaal Bern
Most of the provisions of the TPA and the relevant implementing provisions are to enter into force as originally planned on 1 January 2019. The Federal Council shall determine the date when the provisions come into force.
The latest revision of the Act and the newly proposed amendments to the implementing regulations are designed, in particular, to facilitate market access to medicinal products, improve drug safety and increase transparency.
Swissmedic is responsible for authorisation and issues relating to licensing. In questions on the legislative process at Federal Council level, the Federal Office of Public Health (FOPH) takes the lead. For questions concerning intellectual property rights, please contact the Swiss Federal Institute of Intellectual Property (IPI).
The information to be published will be specified in the revised Article 67 revTPA. These statutory requirements will be implemented in the new Article 67 TPO.
This article will specify the mode of publication of general-interest information relating to therapeutic products, particularly that concerning authorisation and withdrawal decisions and findings connected with market surveillance.
If the majority of the revised Therapeutic Products Act and associated implementing provisions enter into force on schedule at the beginning of 2019, Swissmedic will in future be able to provide information on the following in addition to the information it already provides:
new submissions for authorisation, extensions of indications or authorisation extensions for medicinal products
decisions on the approval, rejection or withdrawal of applications and the revocation of authorisations
the duration of document protection that has been granted
simplified authorisation according to Art. 14 para. 1 let. abis-quater TPA)
findings from market surveillance that are important for therapeutic product safety and information on completed market surveillance activities (e.g. stricter warnings)
summary assessment reports for healthcare professionals (SwissPAR) on approved or rejected authorisation decisions for human medicinal products with new active substances and extensions of the indications for these products.
The official authorisation decision and the text of the official decision will only be issued to the applicant. Swissmedic will continue its practice of not making evaluation reports of new notifications and public evaluation reports available to a broad public. On the other hand, evaluation reports will now include a publicly accessible section that will be published as a SwissPAR (Public Assessment Report).
No, this is not set to change. The requirements to be met by the text and other details that appear on containers and packaging materials are set out in the ordinances1. The ordinances are based on the legal framework prescribed by the legislator. As the authority responsible for enforcing the ordinances, Swissmedic cannot demand that medicinal product packaging show additional information to that required by law.
1Art. 14 of the Therapeutic Products Ordinance (TPO; SR 812.212.21) in conjunction with Art. 12 and Annex 1 number 1ff of the Therapeutic Products Licensing Requirements Ordinance (TPLRO; SR 812.212.22).
The transition will take place under the principle that pending applications submitted before 31 December 2018 will be processed in accordance with the existing TPA (incl. enforcement). Applications submitted after 1 January 2019 will be subject to the new legislation and processed in accordance with the revised TPA (incl. enforcement). The same will apply to the fees charged.