Introduction

Anyone wishing to manufacture and/or trade in medicinal products in Liechtenstein requires a license from the Office of Public Health. The prerequisite for the license is that the companies comply with the internationally recognized rules of Good Manufacturing Practice or Good Distribution Practice. The authorization is limited in time and can be renewed at the request of the company, provided that the requirements are met.

Legal basis

The legal bases are as follows:

• for the customs treaty area, the Federal Act of December 15, 2000 on Medicinal Products and Medical Devices, SR 812.21
• for the EEA, the Act on the Movement of Medicinal Products and the Handling of Human Tissues and Cells in the European Economic Area, LR 812.103.

Procedure for the authorization process

Companies must submit a written application for authorization to the Office of Public Health in the following cases

• before commencing an activity requiring a license
• when changing the details of an existing license
• when requesting an extension of an expiring license

Applications for renewal of licenses must be submitted at least 6 months before the license expires. Manufacturing companies are generally inspected every two years for compliance with GMP regulations. Wholesale companies are inspected every two to four years according to GDP rules, depending on the scope of the authorization.

The subsequent licensing procedure is as follows:

1. Upon receipt, the Office of Public Health examines the application and contacts the applicant.
2. An inspection is then carried out to determine whether the requirements for a license have been met. The inspections are carried out by the Zurich Regional Specialist Unit on behalf of the Office of Public Health.
3. If the requirements are met and an application has been submitted to the Office of Public Health by the Zurich Regional Office of Public Health, the Office issues a temporary permit.

Production in small quantities

Public pharmacies and drugstores can produce small quantities of medicinal products according to their own formula. The preparations are not subject to authorization, but must be reported to the Office of Public Health. The Office of Public Health accepts these notifications, checks the marketability of the medicinal products and issues a confirmation.