Summary of product characteristics

An Investigational Medicinal Product Dossier (IMPD) is intended to be more comprehensive than an IB, in that it should contain summaries of available quality data in addition to the safety and efficacy information that constitutes the main part of the IB. In total, it should provide information on the chemistry, manufacture, control and stability ofthe medicinal product, together with the results of non-clinical and clinical studies. In order to avoid repetition, the IB can be cross-referenced for non-clinical and clinical results. Ideally, the IMPD should follow the same structure as that which will be used later for the marketing authorisation application. For products with existing marketing authorisations, the Summary of Product Characteristics may replace the IMPD to varying extents (see Chapter 6). 

If the medicinal product (s) is currently licensed it is recommended that the current summary of product characteristics (Previously known as the data sheet) is consulted for appropriate contra indications, precautions and warnings. 

Summary of Product Characteristics (SmPC) (for products with marketing authorisation in the Community)... 

Regional Administrative Information Summary of the Dossier Administrative Summary of Product Characteristics 1 1 a lb... 

EU regulations require the submission of a Summary of Product Characteristics (SPC) as part of the product information section. Specific templates and guidance are... 

The requirements for the contents of an application dossier are set out in Annex I of Directive 2001/82/EC. The dossier should be assembled in four parts, as outlined in Figure 7.6. The application form. Summary of Product Characteristics (SPC) and labelling, expert reports and quality sections are quite similar in content to human... 

B. Summary of Product Characteristics Labei and Package insert... 

Effects not mentioned in the Summary of Product Characteristics or of a more severe nature Expedited Reporting... 

Note The MAH holder is also expected to report serious (unexpected) adverse reactions that occurred when the product was used outside the recommended conditions as defined in the Summary of Product Characteristics e.g. overdose, abuse, etc. 

Significant changes in the Summary of Product Characteristics (SPC) such as, the introduction of new contraindications, the introduction of new warnings, the reduction in the recommended dose, the restriction in the indications, the restriction in the availability of the medicinal product. 

The DRA in Venezuela allows prescription drugs to be advertised in the press on a onetime basis as an announcement that the dmg is now registered in Venezuela. Information presented in the promotion and advertising materials must be based on the product information, as specified in the summary of product characteristics (SPC), approved at the time of registration. In all countries except Australia, patient information leaflets and labels are also subject to approval. In Australia, although approval is not needed, the information must not conflict with the approved product information. 

The first of these can be used when a product is to be marketed in a single country. It can be used for any type of application except for certain types of biotechnology-based items. Having been approved in one country, in most cases an application to a second country will trigger the Mutual Recognition procedure in other concerned countries. There are certain exceptions to this, e.g., where a product has different summaries of product characteristics (SmPCs) in different countries, and these have not been subjected to a harmonization procedure. Line extensions to such products could also remain subject to national procedures. 

The equivalence of high and low doses of antidepressants is well known, yet doctors often increase the dose of the antidepressant when their patients do not improve. Why do they do this The official Summary of Product Characteristics for Prozac provides a clue. It notes that in the fixed dose studies of patients with major depression there is a flat dose response curve, providing no suggestion of advantage in terms of efficacy for using higher than the recommended doses . Nevertheless, despite the absence of evidence that higher doses produce better effects, the very same document advises physicians as follows ... 

So when increasing the dose of antidepressants, doctors are merely following the manufacturer s advice, as reported in the Summary of Product Characteristics. 

In our meta-analysis, more than half of the clinical trials submitted to the FDA showed no difference between drug and placebo. Most reviewers of the clinical-trials literature have not had access to unpublished studies and may not even know of their existence. But the FDA and other regulatory agencies around the world knew of these data. Nevertheless, their existence is not even mentioned in the product labels, information leaflets and official Summaries of Product Characteristics (SPC) of most antidepressants. 

A sponsor company or a national authority may make referrals to the EMEA imder Article 10 of Directive 75/319/EEC, in order to harmonize the summary of product characteristics in all member states for products previously approved rmder national legislation. 

The Risk Assessment model comprises (1) prediction of the concentration that will reach the enviromnent (PEC), (2) prediction of the no-effect concentration (PNEC) on a small selection of organisms (3 species), and (3) propose possible minimization measures which will be inserted, in form of standard sentences, in summary of product characteristics (SPC) and/or patient information leaflet of respective Medicinal Product [125]. 

The Summary of Product Characteristics (SPC) for a medicinal product reflects the information in the marketing authorisation of the product. It is prepared by the manufacturer and is intended for health professionals. Updates are necessary to reflect any approved changes by the regulatory body in the marketing authorisation. 

Medicines Control Agency. Guidelines on the Summary of Product Characteristics (SPC) for Human Medicinal Products. Version 3, March 2001. London MHRA,2001. 

Guideline on Summary of Product Characteristics. E.C. Notice to Apphcants Dec. 1999. 

All advertising to health professionals must include certain essential information compatible with the summary of product characteristics or SPC. ... 

This also includes congenital abnormalities/birth defects and serious adverse clinical consequences with use outside the terms of the Summary of Product Characteristics (SPC) including overdoses or abuse. 

Much later. Directive 83/570 required the applicants to produce a draft Summary of Product Characteristics (SPC) as an integral part of the documentation. In September 1995, an order was made (SI 1995/2321) to the effect that, in the United Kingdom, data sheets were no longer required where a product had an approved SPC and also that data sheets no longer had to be sent to all doctors and dentists prior to advertising. 

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