Marketing authorisation

Time frame

How long does it take, in general, to obtain an authorisation from application to grant, what fees are payable and what is the normal period of validity of the authorisation?

In general, ordinary marketing authorisations for medicinal products proceedings take about a year at minimum. The Swiss Agency for Therapeutic Products (Swissmedic) has issued a guideline setting out its internal targeted time periods and milestones. If Swissmedic has queries, or requests further information or documents, the internal targeted time periods are stopped and the authorisation process can take longer.

If the applicant informs Swissmedic well in advance (three to six months) of the date of filing the application for marketing authorisation, Swissmedic offers, under certain conditions, a 20 per cent faster process (procedure with pre-announcement). The fees for the proceedings are then doubled.

If there is no treatment, satisfactory or otherwise, against a perilous or heavily disabling disease, and if the medical preparation is of a high therapeutic value, a fast-track procedure is available upon the applicant’s request. The fast-track procedure must be applied for at least three months before the application for the marketing authorisation is filed. The marketing authorisation procedure can then be completed within about five months. If Swissmedic has queries, the proceedings may take longer.

The fees of Swissmedic for examining applications for marketing authorisations vary depending on the type of application. They are:

  • 80,000 Swiss francs for a new active substance;
  • 30,000 Swiss francs for a product containing an already registered active substance with innovation (simplified procedure);
  • 15,000 Swiss francs for a product containing an already registered active substance without innovation (simplified procedure); and
  • 500 Swiss francs for renewing an existing authorisation.

 

In addition to these fees, Swissmedic charges an annual supervisory fee that is calculated based on the ex-factory price of the medicinal product. The fee amounts to eight per 1000 of the ex-factory price.

The marketing authorisation is initially valid for five years. Swissmedic is entitled to grant a shorter authorisation period in the case of temporary authorisations or for health protection reasons. The authorisation is then renewed upon application if the conditions for authorisation are still fulfilled. The renewed authorisation is generally valid for an unlimited period of time. Swissmedic may, however, also limit the term of the renewed authorisation if necessary.

Protecting research data

What protection or exclusivities apply to the data submitted by originators to gain initial approval and, on variation or new application, to add indications or pharmaceutical forms?

Undisclosed data that has been submitted to the authorities for obtaining a marketing authorisation, the origination of which involves a considerable effort, is protected against unfair commercial use (article 39(3) of the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights 1994). In line with this principle, the Law on Therapeutic Products (LTP) provides 10 years of data exclusivity for original preparations.

Data exclusivity is granted for three years for data filed in support of an authorisation for a medicinal product (original or not) for a new:

  • indication;
  • method of administration;
  • Galenic form; or
  • dosage.

 

For new indications, Swissmedic may grant 10 years of data protection on request when a significant clinical benefit can be expected over existing therapies and the indication is supported by extensive clinical trials.

For a medicinal product specifically and exclusively for paediatric use in accordance with the paediatric investigation plan, Swissmedic may grant data protection of 10 years on request.

For an important medicinal product for a rare disease, Swissmedic may grant data protection of 15 years on request.

Freedom of information

To what extent and when can third parties make freedom of information applications for copies of research data submitted by applicants for authorisation to market medicinal products or medical devices?

After the respective administrative decision has been taken, third parties, in principle, can ask for copies of authorities’ documents based on the Federal Act on Freedom of Information in the Administration. Excepted are, among others, business secrets. Research data submitted by applicants for authorisation to market medicinal products or medical devices that have not been published can, in most situations, be business secrets. The four conditions for information to be a business secret are analysed in detail by Swissmedic and the courts. Regulatory data protection does not per se provide for protection against freedom of information requests as the Swiss Federal Court has ruled in recent years (Case 1C_562/2017 €3.2).

With regard to research data regarding medical devices that are under control of the authorities, the situation is as described above. Conformity assessment bodies are, however, not subject to the Federal Act on Freedom of Information in the Administration.

Regulation of specific medicinal products

Are there specific rules for approval, and rewards or incentives for approval, of particular types of medicinal products, such as traditional herbal and homeopathic products, biologicals and biosimilars, controlled drugs, orphan drugs and those for paediatric use?

A simplified marketing authorisation procedure is available for certain types of medicinal products, such as:

  • complementary and herbal medicinal products;
  • orphan drugs;
  • medicinal products with active substances that have already been authorised in Switzerland;
  • parallel imports from a country with an equivalent marketing authorisation system;
  • medicinal products of which the active substance has been used in a medicinal product authorised in one or more EU or European Free Trade Association (EFTA) countries for at least 10 years and that are comparable with regard to indication, dosage and mode of application;
  • non-prescription medicinal products that, at the time of submission of the application, are proven to have been used medically for at least 30 years, at least 15 years of which have been in EU and EFTA countries; and
  • certain radiopharmaceuticals and antidotes.

 

For certain medicinal products (eg, certain homeopathic and anthroposophical products), authorisation by way of a mere notification procedure is possible.

Swissmedic may grant a marketing authorisation of limited duration based on reduced requirements for medicinal products against life-threatening or seriously disabling diseases if this is compatible with the protection of health, if a significant therapeutic benefit can be expected from the administration of these products and if no equivalent medicinal product is available in Switzerland.

For biologicals containing genetically modified organisms, additional authorisation requirements apply. Swissmedic assesses the product not only in accordance with the regulations of the LTP but also of the Gene Technology Act and the Ordinance on the Handling of Organisms in the Environment.

Rewards in respect of regulatory data protection are granted to certain medicinal products, such as products specifically and exclusively for paediatric use or against orphan diseases.

If the approved product information of a medicinal product reflects all studies performed according to the approved paediatric investigation plan, an extension of the patent protection for six months is furthermore available upon application. The extension can be in the form of an extension of the supplementary protection certificate (SPC) (article 140n of the Patent Act) or, if there is no SPC, in the form of a paediatric supplementary protection certificate (article 140t of the Patent Act).

Post-marketing surveillance of safety

What pharmacovigilance or device vigilance obligations apply to the holder of a relevant authorisation once the product is placed on the market?

Marketing authorisation holders must include a risk management plan, including a pharmacovigilance plan, in applications for marketing authorisation for medicinal products with a new active substance and for new indications of new active substances. A risk management plan is also required for medical devices.

Marketing authorisation holders for medicinal products with a new active substance or biosimilars have to submit periodic safety update reports to Swissmedic during the four years following authorisation and in certain other situations.

Generally, the manufacturer or distributor of therapeutic products must maintain a pharmacovigilance system. The manufacturer or marketing authorisation holder of a medicinal product must notify Swissmedic of any of the following risks relating to medicinal products, which have been observed in Switzerland:

  • serious adverse events;
  • previously unknown adverse events;
  • accumulation of known or previously unknown adverse events, including serious misuse and serious cases of intoxication;
  • quality defects; and
  • unusual distribution restrictions.

 

In relation to risks observed abroad, the following must be notified to Swissmedic:

  • previously unknown risks or new aspects of known risks that are clarified further with regard to risk mitigation measures, that require risk mitigation measures or that have led to risk mitigation measures abroad;
  • accumulation of known or previously unknown adverse events, including serious misuse and serious cases of intoxication; and
  • quality defects if batches that were put on the Swiss market are affected.

 

The person placing a medical device on the market for the first time must notify Swissmedic of serious adverse events in Switzerland. Serious adverse events that occur in other treaty countries have to be notified to the competent authority in the respective country.

In addition, the manufacturer, marketing authorisation holder or distributor of therapeutic products must report suspicion of illegal trade of therapeutic products by third parties, which it discovers in connection with its activities, with one of its products or with its components.

Other authorisations

What authorisations are required to manufacture, import, export or conduct wholesale distribution and storage of medicinal products and medical devices? What type of information needs to be provided to the authorities with an application, what are the fees, and what is the normal period of validity?

Medicinal products

Manufacturing is, in principle, subject to a manufacturing licence from Swissmedic. Hospital pharmacies and other organisations holding a retailing licence may have to apply to the canton.

The criteria for obtaining a manufacturing licence from Swissmedic, in accordance with article 3 et seq of the Ordinance on Establishment Licences of 14 November 2018, are:

  • the applicant is located in Switzerland;
  • the applicant’s facilities operate a system ensuring the pharmaceutical quality of medicinal products and the management and staff in the departments concerned must be actively involved in this system;
  • each department has a sufficient number of qualified and competent staff members to enable it to achieve its quality targets;
  • a qualified person has been appointed for the facilities;
  • the facilities are organised in an appropriate way;
  • the facilities are designed, structured, maintained and modernised regularly to guarantee the safe manufacture of medicinal products, and the premises and equipment that can influence the quality of the medicinal products is approved;
  • a document system is available to provide the working instructions, procedure descriptions and protocols of the relevant manufacturing processes;
  • manufacturing, testing and cleaning procedures are validated;
  • quality control is independent of manufacture;
  • applicable duties of care are fulfilled in the manufacturing process (in particular, manufacture is carried out in accordance with EU good manufacturing practices, as set out in Commission Directive 2003/94/EC on good manufacturing practice for medicinal products); and
  • the work of all persons occupying key positions in the company is set out in job descriptions and their positions in the hierarchy are shown in organisation charts.

 

Swissmedic performs an inspection with regard to these conditions.

The fee for the examination of an application for a licence is 1,500 Swiss francs. Additional fees for the inspection (depending on the time needed) apply. Swissmedic requests additional fees for the examination of inspection reports of regional inspectorates (200 Swiss francs), for the update of the database (100 Swiss francs) and for the issuance of the licence certificate (200 Swiss francs; each attachment: 100 Swiss francs).

Licences granted under the revised LTP do not have a limited duration. Licences granted under the previous law remain valid at least until their expiry date. Swissmedic may withdraw the licence if the conditions for its grant are no longer met or if the licensed activity is not performed for more than 12 months.

The requirements for licences for import, export or conduct of wholesale distribution of medicinal products are similar to those for some variations (articles 11 to 18 of the Ordinance on Establishment Licences). Reduced requirements apply for licences for trading medicinal products abroad or brokerage or agency activities with medicinal products (articles 21 to 26 of the Ordinance on Establishment Licences).

 

Medical devices

Swiss law does not require licences for manufacturing, importing, exporting or conducting wholesale distribution and storage of medical devices. The principle of self-monitoring applies. Conformity assessment bodies need to be accredited or recognised by an international treaty.

Sanctions

What civil, administrative or criminal sanctions can authorities impose on entities or their directors and officers for breach of the requirements concerning controlled activities?

Swissmedic and the cantonal authorities monitor compliance in their respective areas of competence, which are defined in the LTP and related ordinances. They can generally take any administrative measure necessary to enforce the LTP, subject to the principles of proportionality and of public interest. The LTP lists certain possible measures in this regard. For breaches of a licence, Swissmedic can:

  • raise objections and set an appropriate time period for re-establishment of the lawful situation;
  • suspend or revoke the licence;
  • close down the establishment;
  • seize, hold in official storage or destroy medicinal products that endanger health or that do not conform to the LTP; and
  • prohibit the distribution, supply, import, export and trade of medicinal products, order their immediate recall from the market, or order the publication of recommendations of conduct to prevent damage.

 

Swissmedic and the competent cantonal courts can also impose criminal sanctions on entities or their directors, including the confiscation of assets or compensatory claims. Articles 86 and 87 list the breaches of the LTP for which criminal sanctions are foreseen. The criminal sanctions include up to 10 years of imprisonment and a fine (eg, for dealing or distributing unlicensed medicinal products that put the health of patients in danger).

Exemptions

What, if any, manufacture and supply of medicinal products is exempt from the requirement to obtain an approval to market?

There are some exceptions to the requirement to obtain marketing authorisation for medicinal products. The following medicines may be marketed without marketing authorisation:

  1. medicinal products manufactured by hospitals or public pharmacies based on a prescription by a physician for a specific person or a specific circle of persons (magistral formula): the medicinal product can be manufactured ad hoc or for stockpiling, but only dispensed based on a prescription by a physician;
  2. medicinal products manufactured ad hoc or for stockpiling by hospitals, public pharmacies, drugstores or other establishments with a manufacturing licence based on a special monograph of the pharmacopoeia or another recognised dispensary for dispensing to their own clients (officinal formula);
  3. non-prescription medicinal products manufactured ad hoc or for stockpiling by hospitals, public pharmacies, drugstores or other establishments with a manufacturing licence based on their own formula or on a formula published in learned literature and within the dispensing competence of the person responsible for the manufacturing and for dispensing to his or her own clients;
  4. medicinal products for which no alternative equivalent medicinal product is authorised or available and that are manufactured for stockpiling by hospitals based on a hospital internal list of medicinal products and for dispensing to their own clients;
  5. medicinal products for clinical trials; and
  6. medicinal products that cannot be standardised.

 

Manufacturing of the medicinal products listed under items (1) to (4) can be delegated to an establishment with a manufacturing licence, and there are qualitative and quantitative limits for manufacture of these medicinal products.

Parallel trade

Are imports allowed into your jurisdiction of finished products already authorised in another jurisdiction, without the importer having to provide the full particulars normally required to obtain an authorisation to market? What are the requirements?

A company wishing to make parallel imports of medicinal products can apply for a special type of marketing authorisation, which is granted in a simplified procedure. The following conditions must be met:

  • the medicinal product must originate from a country with an authorisation system equivalent to that of Switzerland;
  • the medicinal product must satisfy the same requirements as products already approved in Switzerland; in particular, in relation to labelling and product information; and
  • the parallel importer must be in a position to meet the same safety and quality requirements for the products as the holder of the marketing authorisation for Switzerland.

 

Swissmedic does not consider whether the medicinal product is still patent protected. The defence of patent rights is upon the patent holder.