Marketing and manufacturing authorisation for medicinal products

1/29/2003 | 12:00 AM

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TALLINN, 29 January 2003 - The SAO audited the organisation of issuing retail and wholesale licences as well as manufacturing authorisation for medicinal products in order to see whether the requirements to the applicants are clear and known to all interested parties, and whether the system of licences manages the risks on people’s lives, health, and environment.

The audit found that the officials of the Ministry of Social Affairs and of the State Agency of Medicines have an overview of the undertakings operating in this field, and of their situation. The audit showed that the number of protests filed by enterprises is small, and their activity has not caused any damage to people or environment as far as is known.

Although companies have not filed any protests, and the state has a clear overview of the actors in the medicines market, the SAO recommends a specification to the Medicinal Products Act. The present Act leaves too much freedom of decision for officials issuing licences. The requirements on rooms in a pharmacy are clear, but the requirements on the work experience and in-service training of head of pharmacy have been worded very generally.

In addition, the law does not ensure the independence of pharmacies from wholesalers of medicinal products. The present law prohibits issuing activity licences of retail trade to wholesalers of medicinal products, but does not prohibit one person to own enterprises dealing with different kinds of sale. This may confront consumers with forced choices because all wholesalers are first of all interested in selling their medicinal products.

The Minister of Social Affairs answered that the proposals by the SAO will be taken into account in the preparation of the new draft Medicinal Products Act.

The questions of how medicinal products enterprises cope with the state requirements, and how the requirements are observed in issuing of licences interested the SAO mainly because of the fast development of the medicinal products market: in 1998, the number of pharmacies in Estonia was 251 according to the Agency of Medicines, whereas on 1 July 2002, the number was already 302 (excluding 149 pharmacy branches and other sales facilities). Altogether, there are 450 valid wholesale and retail licences as well as manufacturing authorisations of medicinal products, and over 80% of them have been issued to pharmacies.

Sven Soiver
Press Representative of State Audit Office
Telephone: (372) 640 0787
GSM: (372) 53 414464

  • Posted: 1/29/2003 12:00 AM
  • Last Update: 10/2/2015 6:24 PM
  • Last Review: 10/2/2015 6:24 PM

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