Classification for supply

The classification for supply of medicinal products for human use to the public varied appreciably from one Member State to another, whereas medicinal products sold without prescription in certain Member States could be obtained only on medical prescription in others. Council Directive 92/26/EEC Concerning the classification for the supply of medicinal products for human use was adopted as an initial step towards harmonising the basic principles applicable to the classification for the supply of medicinal products in the Community or in the Member States concerned. The relevant articles in Directive 2001/83/EC are 70-75. 

In all cases, an Expert Report (or its CTD equivalent, the Clinical Overview), which is a critical analysis of the proposed availability of the product without a medical prescription with the dose and indications as stated in the application, must be provided. The expert is expected to take a clear position, defend the proposal in light of current scientific knowledge, and demonstrate why none of the criteria that determine classification for supply subject to a medical prescription applies to the product. 

The MRP has several advantages. The processing time for applications is relatively rapid, and there are several elements of flexibility for the applicant (choice of RMS and CMS, and provision of a draft report). The MRP also allows for approvals to include different trade names in different countries for the same product, unlike the CP (see below). Furthermore, the MRP can be activated repeatedly and incrementally, so as to gradually expand the product application into increasing numbers of MS. It should be noted, however, that MS can differ in their recognitions in classification for supply (prescription-only, over-the-counter, etc.). 

Four to six months before a planned CP submission the applicant has to notify the EMEA of the intention to file an application and provide an estimate for the date of submission. The notification should include information on the product (a draft SmPC), the legal basis for the application (whether complete or abridged), proposal for classification for supply, justification for request of MA using the CP, information on manufacturing and batch release arrangements that may be linked to preauthorization inspections, the proposed product trade name and a stated preference regarding Rapporteur and Co-rapporteur (see below). 

Substances or preparations requiring to be labelled with the risk phrase R45 (may cause cancer) or R49 (may cause cancer by inhalation) under CHIPS are listed in Table 5.16 after the 5th edition of the Approved Supply List (Information approved for the classification and labelling of substances and preparations dangerous for supply). This list excludes certain coal and oil-based substances which attract the phrase R45 only when they contain a certain percentage of a marker substance (e.g. benzene). 

Table 14.5 Classification of and symbols for substances dangerous for supply (Schedule 1 Part I)...

Approved guide to the classification and labelling of substances and preparations dangerous for supply Safe working m confined spaces - Approved Code of Practice, Regulations and guidance - Confined Spaces Regulations 1997... 

Regulate the classification, provision of safety data sheets, labelling and packaging of substances and preparations dangerous for supply. There are specific exceptions, e.g. medicines, pesticides, wastes, radioactive substances or preparations. 

Requirements for labelling of containers for supply may differ from those for conveyance. Key features of a supply label are to identify the substance (the chemical name in most cases) and any hazards and safety precuations. In Europe the classification, packaging and labelling of dangerous substances is covered by Directive 67/548/EEC as amended. This requires labels to identify appropriate risk and safety phrases (Tables 12.2 and 12.3) depending upon product properties. A substance is considered dangerous if in Part lA of an approved list or if it exhibits hazardous properties as defined in Schedule 1 for supply, or Schedule 2 for conveyance as shown in Tables 12.4 and 12.5. Substances not tested should be labelled Caution — substance not yet fully tested . Criteria for risk phrases are provided, e.g. as in Table 12.6 for toxic compounds. 

COP22 Dangerous substances Classification and labelling of substances dangerous for supply. 

Article 1 of Council Directive 92/26/EEC provides two classifications for the supply of medicinal products for human use in the community ... 

There is also an EU guideline (dated 29 September 1998 and in operation since January 1999) on changing the classification for the supply of a medicinal product for human use. Article 3 predetermines the POM products. Therefore, the criteria in Article 3 have been used as a basis for this guideline. This guideline does not address the different restrictions that may be available for medicinal products not subject to a medical prescription, such as available in pharmacies only following initial medical diagnosis, or available on general sale, as the case may be. 

Part 2 of this guideline describes the data required for changing the classification. The documentation required concerning safety and efficacy in support of an application for a change in the classification for the supply will depend on the nature of the active substance and the extent... 

European Commission Director General III. A Guideline on Changing the Classification for the Supply of a Medicinal Product for Human Use. 12 July 1997. 

Approved Supply List [4th Edition] - Information Approved for the Classification and Labelling of Substances and Preparations Dangerous for Supply, HM Stationery Office, 1998. 

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