Production and wholesale

Introduction

Anyone wishing to manufacture and/or trade in medicinal products in Liechtenstein requires a license from the Office of Public Health. A prerequisite for the permit is that the establishments comply with the internationally recognized rules of good manufacturing practice or good distribution practice. The permit is limited in time and can be extended again upon application by the company, provided that the requirements are met.

Legal basis

The legal bases are as follows:

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

Process of the authorization procedure

Establishments must submit a written application for a permit to the Office of Public Health in the following cases:

• before commencing an activity requiring a permit
• when information in an existing permit is changed
• when requesting renewal of an expiring permit

Applications for renewal of permits shall be submitted at least 6 months prior to the expiration date of the permit  . Manufacturing facilities are generally reviewed every two years for compliance with GMP rules. Wholesale facilities are inspected every two to four years for compliance with GDP rules, depending on the scope of the permit.

The subsequent course of the licensing procedure is as follows:

1. On receipt, the Office of Public Health reviews the application and contacts the applicant.
2. Thereafter, an inspection is conducted to determine whether the requirements for a permit have been met. The inspections are carried out on behalf of the Office of Public Health by the Zurich Regional Office.
3. If the requirements are met and there is an application from the Regional Office Zurich to the Office of Health, the Office will issue a temporary permit.

Production in small quantities

Public pharmacies or drugstores can manufacture medicines according to their own formula in small quantities. The preparations are not subject to licensing, but must be reported to the Office of Public Health. The Office of Public Health receives these notifications, verifies the marketability of the medicines and issues a confirmation.