Wholesale Distribution of Medicinal Products

Sites that warehouse and engage in the wholesale distribution of medicinal products are also subject to similar authorisation procedures. The sites must have suitable premises to properly store and preserve the products, employ a designated qualified 

1 Brief information on the firm (including name and address), relation to other sites and, particularly, any information relevant to understand the manufacturing operations. 

2 Pharmaceutical manufacturing activities as licensed by the Competent Authorities. 

4 Name and exact address of the site, including telephone, fax and 24-hour telephone numbers. 

5 Type of actual products manufactured on the site, and information about specifically toxic or hazardous substances handled, mentioning the way they are manufactured (in dedicated facilities or on a campaign basis). 

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This activity, established under the Medicines Act, still remains wholly within the remit of national authorities but in accordance with Council Directive 92/25/EEC of 31 March 1992 on the wholesale distribution of medicinal products for human use (now Articles 76-85 of Directive 2001/83/EC). 

The EU has also developed a specific Directive for the wholesale distribution of medicinal products. The Directive places similar emphasis on the topics specified in U.S. legislation with... 

EU Directive 92/25/EEC on Wholesale Distribution of Medicinal Products for Human Use. 

Title VI Possession, distribution and dis- Tide VI Classification of medicinal products Tide VII Wholesale distribution of medic-... 

Despite the fact that some French manufacturers had representatives in charge of medicinal products for import and distribution, the task was commonly carried out by wholesalers, distributors or by pharmacists themselves. 

This Executive Order lays down provisions for the manufacture of medicinal products, including manufacture intended for export, and for import, wholesale and retail distribution, including stock holding of medicinal products. 

Distribution of medicines by licensed Wholesalers is controlled by the European Commission Guidelines of 5th November 2013 on Good Distribution Practice of medicinal products for human use (2013/C 343/01). 

Regulation 3(1) of the 1994 Regulations states that no medicinal product may be placed on the market or distributed by way of wholesale dealing, unless it has a marketing authorisation. This replaces the product licence requirement in section 7 of the act. The exemptions to this requirement are provided for by regulation 3(2) and Schedule 1 to the regulations. They permit supply for individual patients and also enable practitioners to hold limited supplies of stocks of imauthorised medicines. The provisions apply equally to doctors and dentists. 

Wholesale distribution Any type of activity consisting of procuring, holding, supplying or exporting medicinal products, apart from supplying medicinal products to the public. 

There are also wholesalers who have retail chains, and supply other retailers, and in both countries they buy locally as well as from importers. One such pharmaceutical wholesaler in Tanzania explained that there was demand for both Tanzanian and Kenyan medicines however, there were constant shortages of Tanzanian items, whereas Kenyan products are always available in the market. Kenyan suppliers such as Elys have representatives in Tanzania, and their products are widely distributed there. 

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