Rules of reservation

Reservation of bearer prescription medicinal products

 

1. Rules for Acquisition of Bearer prescription medicinal products (hereinafter the Rules) govern the prescription, distribution and sales (issue) of bearer prescription medicinal products.

2. The Rules do not apply to the following medicinal preparations:

2.1. narcotic medicinal products (except where the personal health care institution acquires the medicinal preparation included in the list of necessary bearer prescription medicinal products approved by the head of the institution);

2.2. homeopathic and anthroposophic (with the exception of medicinal preparations with therapeutic approved indications, registered in the European Economic Area member states (hereinafter the EEC countries);

2.3. vegetative (other than registered in the EEA countries);

2.4. subjects;

2.5. extemporal;

2.6. imported or received by post, by a natural person for personal use only.

3. Bearer prescription medicinal products may be administered only in accordance with the requirements laid down in these Rules. The doctor, in prescribing the bearer prescription medicinal products for individual patients, is directly and personally responsible for them according to the provisions of the Law on the Patient Rights and Compensation for Damage to Health of the Republic of Lithuania (Official Gazette, 1996, No. 102-2317; 2004 No. 115-4284) and other legislation, and taking into account paragraph 4 of the Rules.

4. The bearer prescription medicinal product must be registered in at least one other EEA country or the manufacturer’s country. State Medicines Control Agency under the Ministry of Health of the Republic of Lithuania (hereinafter the Agency) is not responsible for the quality, security, and efficiency of the prescribed bearer prescription medicinal product, except when the prescribed preparation is included in the Register of medicinal products of the Republic of Lithuania, but its packaging and (or) a packaging leaflet are prepared in other than the Lithuanian language.

5. The bearer prescription medicinal products can be imported from other EEA countries or from third countries (hereinafter import) only by legal persons having medicinal product wholesale distribution licenses (hereinafter the distribution company).

6. In implementing the requirements of these Rules it is important to ensure that all individuals prescribing, ordering, supplying and selling (issuing) the bearer prescription medicinal product, as well as patients taking this medicine, know (be informed) that the market right in the territory of the Republic of Lithuania is not granted for the bearer prescription medicinal product, and therefore all decisions relating to the product must be taken into account and implemented very responsibly.

7. The advertising of bearer prescription medicinal products is not allowed. Information about the bearer prescription medicinal product must be provided only to interested persons.

8. In accordance with these Rules, medicinal products, which are recorded in the register of medicinal products of the Republic of Lithuania or the European Community, but do not meet the registration conditions (e.g., their packing is in non-Lithuanian language).

9. The main definitions used in the Rules:

Medicinal products not granted marketing authorisation are the medicinal products not included in the Register of Medicinal Products of the Republic of Lithuania;

Bearer prescription medicinal product means a medicinal product to which marketing authorisation has not been granted which is indispensable for an individual patient, supplied to the Republic of Lithuania on the prescription of the patient’s doctor, submitted according to the procedure established in these Rules and intended to be used under direct responsibility of the doctor.

 Statement on prescription of the bearer prescription medicinal product (hereinafter the Statement) is a document by which the doctor confirms the need for the prescription of the bearer prescription medicinal product to the patient and the patient (his representative confirms the consent to use the bearer prescription medicinal product.