Wholesale dealer s licence

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 ... 

Section 8(3) of the act requires those involved in the wholesale dealing of a medicinal product to hold a wholesale dealer s licence. If the product is imported from another Member State, a wholesale dealer s licence will be required. If it is... 

The distribution of medicines from manufacturer to retailer is mainly a private function, the wholesaler covering their costs and earning their profit through the margin allowed in the retail price. The wholesale dealer s licence, among other things, seeks to ensure adequate record keeping, in case a batch of medicines has to be recalled. 

Please refer to List of documents Required to Be Submitted When Appl5dng For An Import Licence Or Wholesale Dealer s Licence for Medicinal Products that is enclosed. 

List of Documents Required to be Submitted When Applying for an Import Licence or Wholesale Dealer s Licence for Medicinal Products... 

Under the Medicines Act, the licensing system for MAs, Manufacturer s, and Wholesale Dealer s Licences, and for Clinical Trial Certificates, allows the opportunity for an applicant or licence holder to appeal against an unfavourable recommendation or decision, right up to the High Court if necessary, although that has rarely happened. Nevertheless, appeals to the appropriate advisory committee such as the Committee on Safety of Medicines, and to the Medicines Commission, are commonplace in the process leading to grant of an MA. Appeals may also arise in connection with the suspension, revocation, or compulsory variation of MAs or certificates. Manufacturer s Licences and Wholesale Dealer s Licences are rarely subject of the need for such appeal action. 

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