Patient information marketing authorisation

An application for a marketing authorisation must be accompanied, among other items, by specified pharmaceutical, preclinical and clinical particulars and documents (the dossier ). Three important summary documents in the dossier are the SPC, a Package or Patient Information Leaflet (PIL), and the sales presentation of the product (label). The SPC has a formally prescribed structure (Box 17.1), and forms the basis for authorised chnical prescribing of the medicinal product concerned. 

Part I was a summary of the information presented in the whole dossier and included the application forms and administrative particulars on fees, various declarations and the t)rpe of application as well as particulars of the marketing authorisation (lA), proposed SPC (IBl), proposals for packaging, labels and package or patient information leaflets (IB2), and any SPCs already approved in the Member State(s) for the particular product (IB3). Also included were separate Expert Reports on chemical and pharmaceutical (ICl), pharmacotoxicological (preclinical) (IC2), and chnical documentations (IC3), as... 

If the decision is favourable, the drug is granted a marketing authorisation (for 5 years renewable), which allows it to be marketed for specified therapeutic uses. The authority must satisfy itself of the adequacy of the information to be provided to prescribers in a Summary of Product Characteristics (SPC) and also a Patient Information Leaflet (PIL). 

Spontaneous ADR report A case report relating to an individual patient describing a suspected adverse reaction (see p. 33). Summary of Product Characteristics A regulatory document attached to the marketing authorisation which forms the basis of the product information made available to prescribers and patients (see p. 52-3). 

Traditionally, the pharmacist combined preparation, control and dispensing. He was held responsible as a person when a patient was harmed. In addition, when a pharmacist suspected an error in a prescription of a physician he initiated a relevant action. Also when a patient reported an adverse event, the pharmacist informed authorities and industrial parties, the Marketing Authorisation Holder. 

Dealing with medical information and complaints of HCP s and patients is another duty that relates to a potential non-compliance with the marketing authorisation off label use, medical related complaints. 

When tablets may be subdivided and they have a break-mark, the halves have to comply with the requirements on the uniformity of mass of the Ph. Eur. under Subdivision of tablets [2]. Up till now these requirements only apply for scored tablets where subdivision is necessary to meet all the doses that are mentioned in the product information, not for break-marks intended to ease swallowing. There are also requirements proposed on the loss of mass by subdivision and the ease of breaking. In a Dutch study on a representative selection of tablets with a market authorisation only 24 % complied with the requirements on the uniformity of mass of the halves, and 34 % with the proposed standards on ease of subdivision [19]. These results were comparable to those of other studies on patient experiences with the performance of score lines [16, 17]. A so called tablet splitter can be useful (Fig. 37.3), although it does not always give better results than a kitchen knife or breaking by hand. 

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