Article 75 of the Convention implementing the Schengen Agreement lays down provisions on a certificate which private persons wishing to travel within the Schengen Area and carry pharmaceutical preparations containing narcotic drugs and/or psychotropic substances can use to prove that these preparations are necessary for their medical treatment. In addition to Finland, the Schengen member states comprise Austria, Belgium, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Iceland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden and Switzerland.
The Schengen certificate can be obtained from pharmacies
According to an amendment to the Medicines Act, which entered into effect in 2003, pharmacies can issue the certificate but only to persons residing permanently in Finland. The Ministry of Social Affairs and Health's circular to pharmacies on 14 January 2003 states that the certificate is drawn up when requested by a person and the pharmacy may charge a reasonable fee for it.
The certificate can be issued for pharmaceutical preparations containing narcotic drugs or psychotropic substances. The preparations that have been granted a marketing authorisation can be found in the FimeaWeb service. When the name of the preparation is entered into the service and looked up, an entry indicating that the Schengen certificate is required can be found in the product information.
Figure 1. Picture of product information in the FimeaWeb search when the Schengen certificate is required for the preparation.
The certificate can also be issued for pharmaceutical preparations subject to a special permit and ex tempore preparations that contain narcotic drugs or psychotropical substances. The certificate can also be written for dose-dispensed products. However, the dose bags must clearly indicate who the products are for and what products the dose-dispensing bag in question contains. The Schengen certificate procedure is not applied to products containing a substance nationally classified as a narcotic drug. Examples of such substances are lisdexamfetamine or tapentadol.
According to the decision of the Executive Committee, a separate certificate is required for each narcotic drug prescribed by a doctor. When applying for the certificate, the person must bring along a travel document, usually a passport, or an ID card. The number of the passport or ID card is recorded in the certificate. If the person will be travelling in the Nordic countries and does not have a passport, their personal identity code can also be recorded in the certificate. The certificate can also be applied for on behalf of another person by using an authorisation, in which case a travel document should also be presented.
A pharmacy or subsidiary pharmacy completes the certificate available on Fimea’s website and signs it. The certificate can be issued when the pharmaceutical preparation is dispensed or afterwards by a pharmacy, which verifies the details of the prescription from the Prescription Centre. The certificate is valid for 30 days, but the duration of the trip may be shorter. However, the certificate cannot be issued for medication lasting longer than 30 days. The practical advice for longer trips is to contact local health care during that time if the person continues to stay in the country.
Different countries may require the certificate for different preparations, however the principle is to use the certificate in a consistent manner. The best way for the person travelling to find information on restrictions in the destination country is to enquire from the mission or embassy of the country in question.
Provisions on when the certificate is required on arrival in Finland are laid down in the Government Decree on Importing Medicinal Products to Finland for Personal Use (1088/2002). To be able to import a pharmaceutical preparations containing narcotic drugs or psychotropic substances from a Schengen country, the person is required to present the Schengen certificate for importing this specific preparation. The prescription on which the certificate and the purchase of the medicinal product are based must have been written in the principal country of residence of the person importing the medicinal product.
Pharmaceutical Officer / Fimea, Valvonta ja saatavuus, Luvat ja tarkastukset -yksikkö, Apteekki- ja huumausainevalvonta tel. +358295223225 email@example.com