Medicinal wholesale direction

Manufacturers, importers and wholesalers may only sell medicinal products directly to pharmacies emd they may, if authorised by INFARMED, after hearing the opinion of the Department of Competition and Prices also ... 

The regulations introduce a number of amendments into Schedule 3 (standard provisions for wholesale dealer s licences) of the Medicines (Standard Provisions for Licences and Certificates) Regulations 1971. The 1999 Regulations reproduce the relevant wording from the Directive (including the reference to special needs ). Supply of an exempt imported product falling within the scope of this wording is only permitted provided certain conditions are complied with ... 

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. 

Companies licensed by the Competent Authority to manufacture are also licensed to supply those items for which they have been granted a Marketing Authorisation. They can sell directly to pharmacies and elsewhere in the medicines supply chain e.g. to licensed wholesalers and registered pharmacies. A number of bulk items such as intravenous fluids are often supplied directly to pharmacies. 

Today, local and international procurement for the public health facilities is mainly provided by the PFSA which operates with a revolving fund. PFSA procurement is done through international and local tenders as well as through direct purchasing. The PFSA also receives some pharmaceuticals through donation from sponsors of vertical programmes such as those for ARVs, TB and malaria medication and reproductive health commodities. From its central hub in Addis Ababa and the regional hubs, PFSA distributes medicines and medical supplies directly to health care facilities. Private companies import directly from their respective suppliers and distribute to wholesalers, and these in turn sell to retailers. 

All collected fees from patients, but only the hospital retained them the dispensaries deposited them with the DMO. The DMO had access to a donor-supported basket fund like the budgets for the district at the public wholesaler, these were sometimes deposited with a delay. The dispensaries applied to the DMO for gap-filling from the basket the hospital also used its fees for this purpose. The hospital pharmacist would cycle off directly to buy urgent essentials at district-designated pharmacies. In the hospital, most essential medicines on our list were there, but barely, with little backup stock. 

As Table 8.1 showed, MEDS was buying a high proportion of their basic essential medicines from local manufacturers. This success in local purchasing reflected a strong capability for local procurement built up over a number of years.In contrast to the Kenyan public wholesaler, MEDS issues only local tenders for medicines and supplies, with no direct importing. Two local tenders a year go only to MEDS s pre-quali-fied supplier pool of local manufactmers and distributors. 

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