Manufacturers licence holders

Liability (public health obligation) issues specify that MA holders must report to the MRA the cessation of marketing of any medicine when the last lot is delivered or at least three months before the manufacturing is terminated. Temporary marketing problems must cilso be reported. Wholesale and pharmacy licence holders may not deny purchase and selling of any medicines with valid Hungarian MA. Serious health injuries or deaths caused by a medicine in full compliance with... 

A wholescile dealer s licence (Appendix 5) is issued to a person who is not the holder of the product or manufacturer licence, for the purpose of selling registered medicinal products to another company for rescile. The applicant must be a locally registered compgmy. 

The manufacturer or product licence holder would have to submit the following information to the Licensing Authority ... 

Letter issued by the new product licence holder confirming that there are no changes to the product or other details submitted previously and that the product is currently registered in the country of manufacture. If there are other changes, the relevant DRA form and documents are also to be submitted in addition to DRA-2 form. 

Change of name of product owner Minor (DRA-3) Letter issued by the product owner authorising the product licence holder to hold the product licence in Singapore Letter by the product owner to authorise the manufacturer to manufacture on its behalf if the product owner is not the memufacturer B3... 

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. 

Storage licences are granted under stringent conditions. One of the principal conditions is that the medicine must be irreplaceable in The Netherlands and/or that patients cannot be treated satisfactorily with legally available products. Importation by the manufacturer or MA holder and delivery by the pharmacist is permitted, without, however, the prohibition of sale being lifted. All that can happen is that the manufacturer/importer and deliverer will be reimbursed for their expenses. 

Many importing countries require proof of registration of medicinal products in the country of origin before sales are permitted. To assist local manufacturers with export markets, the National Pharmaceutical Administration issues Certificates for Exporter of Medicinal Products to holders of product licences whose locally manufactured products conform to required standards of quality (See Appendix 7). The WHO format is used. 

The MCA also provides a Certificate of Manufacturing Status for all holders of Manufacturer s and Assembler s Licences with sites in the UK and a Certificate of Manufacturing Status for tendering purposes. 

The product is manufactured and assembled by the holder of the appropriate licence (see above) ... 

The UK Cookson Group s, Cookson Electronics subsidiary has negotiated licences with the patent holders of various lead-free solders. These enable it to manufacture globally and supply them as a patent holder, making royalty payments on sales. The alloys concerned are Senju Sn/Ag/Cu (Senju-... 

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