"Small import" of medicinal specialties
Small import" of medicinal specialities according to § 11 para. 1 Z 7 of the Austrian Medicinal Products Import ActTheFederal Office for Safety in Health Care takes the liberty to state with regard to the exceptional provision of the so-called "small import" of medicinal specialities from the EEA by public pharmacies according to § 11 para. 1 Z 7 of the Austrian Medicinal Products Import Act that this is only permitted in compliance with the requirements according to § 11 para. 3 to 5 of the Austrian Medicinal Products Import Act. Accordingly, the transfer of proprietary medicinal products from an EEA country by an Austrian public pharmacy - without notification to the Federal Office for Safety in Health Care - is only possible if:- the medicinal product is legally marketed in the country of origin of the EEA- it is a medicinal product for human use- the medicinal product is intended to be passed on to specific persons for their personal use (there must be a specific order for a patient in the pharmacy that is known at the time of the order)- the quantity of the medicinal product for this person must be three times the quantity required for the patient in question.the quantity intended for this person does not exceed three commercial packages of a proprietary medicinal product intended for supply to private individuals- if the proprietary medicinal product is subject to prescription in the country of origin of the EEA, a medical or dental prescription must be presentedPursuant to Section 11 para. 5 of the Medicinal Products Import Act, the public pharmacy must provide information on the purchase within the scope of the "small import" pursuant to para. 1 line 7 of the Medicinal Products Import Act, which must contain precise documentation of the order process and at least the following information:- Designation of the proprietary medicinal product- Number of commercial packages with indication of the package sizes- Contracting Party of the EEA from which the proprietary medicinal product was purchased and the supplier company located there- Price at which the proprietary medicinal product was purchased-Recipient of the medicinal product- If applicable, name and professional domicile of the prescribing physician or dentistThese records must be kept at the pharmacy for at least five years and must be kept available for inspection by the Federal Office for Safety in Health Care.The transfer of human medicinal products within the framework of "small imports" without there being a concrete reference to a patient in the pharmacy at the time of the order is therefore unlawful.
Inquiries - technical: Institute Monitoring Tel.: +43 (0)50 555-36401 E-mail: inspektionen@ages.at
Queries (for media):
Communications Management,
Tel.: 050555/25000
E-mail: presse@ages.at
