Pharmaceutical /Medicine/Drug/OTC registration in Switzerland

MOH –Federal Office of Public Health

 MOH Website- https://www.bag.admin.ch/

Regulatory Authority-The Swiss Agency for Therapeutic Products

Regulatory Website-https://www.swissmedic.ch/

Local Authorized Representative Required-Yes

Drug Approval Process

Ordinary Process

When the necessary paperwork and information are sent to Swissmedic, the regular process begins. The Ordinance on the Requirements for Marketing Authorization of Medicinal Products and related guidelines contain a list of the necessary papers. Swissmedic offers a “Directory Overview of documents to be submitted,” in particular. According to the requirements for obtaining a marketing authorization, all supporting paperwork for the pharmaceutical product must attest to its superior quality, safety, and effectiveness. Swissmedic mandates that applications be submitted using standard formats and the International Conference on Harmonization’s common technical document format (CTD). For optimum processing efficiency, Swissmedicadvises electronic data submission.

The standard process requires a minimum of a year. Swissmedic published a guideline outlining the authorization process timeline as well as the deadlines Swissmedic aims to meet for applications for authorization that have been submitted. Targeted time constraints for the standard method are as follows: 30 days for the formal control, 120 days for the first assessment phase and question list creation, 90 days for the second evaluation process and tentative conclusion, and 90 days for the final decision. These deadlines are merely meant to serve as recommendations. Swissmedic may need further information or documentation, which could delay the authorization process.

Expedited Process

A fast-track procedure is available upon the applicant’s request, provided that all of the following requirements are met in aggregate: (i) the medicinal product promises treatment or prevention of a severe, debilitating, or life-threatening disease; (ii) treatment with currently approved medicinal products is either unsatisfactory or unavailable; and (iii) the new medicinal product is anticipated to have a high therapeutic value. To enable Swiss Medic to approve the procedure and plan resources ahead of time, applications for a fast-track procedure must be submitted no later than three months before to the application for marketing authorization. With the help of this process, marketing authorization can be obtained four to five months after the application is submitted.

Swissmedic provides a procedure with advance notice that is comparable to the fast-track procedure. This process is accessible upon request by the applicant and is applicable to pharmaceuticals with novel active ingredients, pharmaceuticals with well-known active ingredients that cannot be approved through the streamlined process, and pharmaceuticals with supplementary indications. It makes it possible to receive marketing authorization 20% faster than using the standard process. The applicant must, however, consent to a significant rise in the fees.

Simplified Process

Certain kinds of pharmaceutical products, such as those containing already-approved active ingredients, those originating from nations with comparable marketing authorization systems, and complementary medicines, are eligible for a streamlined process. Swissmedic’s associated guidelines and the Ordinance on the Simplified Marketing Authorization of Medicinal Products and Authorization by Way of Notification oversee the process.

Labelling Requirements

The Swissmedic guideline and the Ordinance on the Requirements for Marketing Authorization of Medicinal Products govern the labeling of pharmaceuticals. The package of medications meant for the patient must, among other things, have the following information:

If required, include the name of the medication along with the dosage and galenic form.

• Composition of the pharmaceutical item.
• Holder of a marketing authorization.
• Number of batches.
• Important medical advice for the product’s use.
• Expiry date.
• Storage guidelines.
• Authorization number for marketing.
• A caution about children and a reminder to read the packaging leaflet.
  

                                              Generic Drug Approval      

  Since the market authorization is specific to a certain product and is personal, generic versions of pharmaceuticals need their own independent authorization. The streamlined authorization process is accessible for the marketing authorization of generic products. The application may refer to the results of one or more reference products’ pharmacological, toxicological, and clinical testing that have been approved by Swissmedic in the past or present, given that the original medicinal product’s applicant has given written consent or the product’s protection period has passed. This 10-year protection period is normally given to the documentation associated with an original pharmaceutical product that includes at least one novel active ingredient. It needs to be separated from the patent-derived protection.

                                                Pharmacovigilance

  Marketing authorization holders are required to set up a pharmacovigilance system and fulfill numerousSwiss medic notification and reporting requirements. Specifically, within the four years following the marketing authorization, holders of a periodic safety update report for a pharmaceutical product containing a novel active ingredient are required to submit it.

  The Swiss medic National Pharmacovigilance Centre accepts and processes reports of adverse drug reactions from professionals. The National Pharmacovigilance Centre is supported by five regional center’s that are each affiliated to a university department; in particular, these process reports from healthcare professionals that involve an important safety signal. For its part, the pharmaceutical industry forwards report of adverse reactions that it receives to Swiss medic. The National Pharmacovigilance Centre works closely with the World Health Organization (WHO) international Centre for drug safety.

  The new Therapeutic Products Act, which went into effect on January 1, 2019, requires that any other medically significant adverse reaction, as well as any serious adverse reactions that have not been previously reported or have not been adequately documented in the product information leaflet of the medicine in question.

  Serious adverse reactions are defined as follows:

• cause mortality,
• life-threatening,
• cause or worsen hospitalization,
• entail a chronic disability or incapacity,
• otherwise, to be deemed medically significant (for instance, if one of the events could have been avoided with prompt medical attention)

  Within 15 days of diagnosis, these probable adverse events should be reported; non-serious reactions should be reported within 60 days.

  The Swissmedic pharmacovigilance team carefully screens all incoming reports for new risks. If a new risk is identified, the need for action is evaluated and appropriate measures are taken in collaboration with the Swissmedic department responsible for the drug concerned.

                                                         Import of Medicine

  Under trademark law, parallel imports of pharmaceuticals or medical devices into Switzerland are not subject to restrictions because the international exhaustion principle governs such imports. In terms of patent law, Switzerland follows the principle of regional exhaustion, which allows a product that the patent owner places in an EEA state to be imported into Switzerland from the EEA without the patent owner’s permission. The principle of national exhaustion, however, nonetheless holds true for medications if the relevant medicinal product’s price is set by Swiss or foreign government authorities. In this instance, the product’s parallel import into Switzerland is subject to the patent owner’s approval.
  
  

• License Validity – 5 years