Licence requirements

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. 

Amanda is a 33-year-old woman whose case we inherited after she had been prescribed diamorphine in controversial circumstances. She had previously been a patient of the methadone clinic but her progress had generally been unsatisfactory, and eventually she had obtained treatment with diamorphine from a doctor in private practice. Unfortunately the doctor did not have the licence required to prescribe the drug, but by the time the situation was discovered treatment had been established for several months. It was agreed that we would take her back into our service, where diamorphine could be prescribed on a legal footing while her case was being reassessed. 

Prolexys www.ariadnegenomics.com/products/prolexys/ Licence required Prolexys HyNet Human interactome ... 

Preferably for large production runs, to minimise the process costs including machinery requirements No licence required, including corresponding restrictions and costs... 

Specifications in pharmacopeial monographs and product licences require intravenous immunoglobulin products to be free from significant amounts of anti-A and anti-B antibodies (132). It has been advised that a specification be adopted that will prevent the use of batches of intravenous immunoglobulin with abnormally high anti-D titers (over 1 64) (132). 

Example of consideration of access at an early stage due to licence requirements... 

In the Crown Court there is no maximum fine. Up to two years imprisonment may be imposed for breach of a prohibition or improvement notice or remedy order or contravening a licence requirement. HSC Enforcement Policy includes a statement that wherever appropriate enforcing authorities should seek disqualification of directors under the Company Directors Disqualification Act 1986. Disqualification is possible on conviction for an indictable offence in connection with the management of a company . In a health and safety context disqualification could follow conviction xmder s. 37 HSW because a company s offence was committed with a director s/manager s consent, connivance or attributable to his neglect (or xmder s. 36 if it is a manager whose default caused the offence of another). 

No special government licence requirements May require government licence... 

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