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Glossary

Selected Terms & Acronyms Relating to Generic Medicines

A compendium of definitions to assist the non-expert reader with the terminology used in discussing the development, production and marketing of generic medicnes.*

Active moiety

In chemistry, a moiety is a group of atoms forming part of a molecule. In the case of a pharmaceutical product, the active moiety is that part of the molecule of an active substance which gives it its therapeutic effect.

Annex I

Annex I to the Directive 2001/83/EC on the Community Code relating to medicinal products for human use. This document lays out the scientific and administrative procedures and requirements which must be met when a company applies for marketing authorisation for a medicinal product. The latest version was published in the Official Journal L 159 of 27.6.2003 and entered into effect on 1 November 2003.

API

Active Pharmaceutical Ingredient

ATC code

Anatomical Therapeutic Chemical classification system

Bioavailability

The rate and extent at which an active moietyor active substance is absorbed (both speed and amount) by the body when introduced in a given dosage form (capsule, tablet, injectable, suppository, etc).

Bioequivalence

Two medicines are bioequivalent when they contain the same amount of an identical active moiety, and when their bioavailability is the same when administered in equal doses under equal conditions. Strict scientific criteria exist for running bioequivalence studies.

Biosimilar product/medicine

An off-patent biological medicinal product which is produced by manufacturers other than the originator and which is similar to the originator product. They are called biosimilar products or medicines because biological medicines produced by different manufacturers are not strictly identical, but similar. Once approved by the competent authorities, biosimilar products are not significantly different in terms of quality, safety and efficacy from the originator product. See: similar biological medicine.

Biological medicinal product

A medicine where the active substance is a biological substance as opposed to a chemical substance. The biological substance is produced by or extracted from a biological source.

“Bolar” provision

A legal provision which allows a generic company to perform the research and development needed to apply for marketing authorisation for a generic medicine before the patent has expired on the originator product without violating patent law. This allows the generic medicine to be available to patients immediately after the the expiry of the originator product’s patent and data exclusivity periods.

Budget headroom

Margin within a budget to pay for additional or increasing costs. The use of generic medicines saves an estimated €18 billion per year which allows the necessary budget headroom for national healthcare systems to provide patients with more expensive treatments and services.

CADREAC

Collaboration Agreement between Drug Regulatory Authorities in European Union Associated Countries (Grouping of Central and Eastern European regulatory agencies).

CEEC

Central and Eastern Europen Countries

Centralised Procedure

The Centralised Procedure is one of two different routes for authorising medicinal products for marketing and use in the European Union. It entails submission of an application to the EMEA and is obligatory for certain pharmaceuticals, such as those derived from biotechnology, and is optional for others. The marketing authorisation granted is valid in all countries of the EEA. See: Decentralised Procedure and Mutual Recognition Procedure.

CPMP

Committee for Proprietary Medicinal Products

CPT

Consumer Project for Technology

CTD

Common Technical Document

Data exclusivity

The period of time during which the medicines authorities are not allowed to consult the dossier of an originator pharmaceutical to verify the safety and efficacy of the active moiety in the application for marketing authorisation of a generic medicine. Data exclusivity periods may extend beyond the patent protection period of a pharmaceutical product, thus delaying the availability of lower-priced generic medicines to patients.

DDD

Defined Daily Dose

Decentralised Procedure

The Decentralised Procedure represents a new means of applying for marketing authorising for a generic medicine in the EU. It will become available in late 2005 and consists of a single application submitted simultaneously to all Member States, who will determine the merits of the application collectively. See also: Centralised Procedure and Mutual Recognition Procedure.

DG

Directorate General of the European Commission

DMF

Drug Master File

Dosage form

The physical form in which a pharmaceutical product is presented to patients for therapeutic treatment as determined by their intended route of administration. Well-known examples of different dosage forms include: capsules, tablets, injectables, suppositories, and liquids.

EDQM

European Directorate for the Quality of Medicines of the Council of Europe

EEA

European Economic Area

EGA

European Generic medicines Association

EHFG

European Health Forum Gastein

EMACOLEX

European Medicines Agencies Co-operation on Legal and Legislative issues. (Informal group of legal experts from the Commission and Member States)

EMEA

The European Medicines Agency is responsible for evaluating medicinal products and providing advice on research and development programmes and maintaining various databases available to healthcare professionals and the public. It is also responsible for granting single European marketing authorisations for medicines through the Centralised Procedure and for arbitrating in case of disputes. The EMEA is based in London and has been known as the EMA since May 2004.

EPAR

European Public Assessment Report

EPP

European Peoples’ Party (often seen in French: PPE)

Essentially similar

Essentially similar is used to describe a pharmaceutical product which has the same amount of the active moiety in the same dosage form as the originator product, and has been shown to be bioequivalent to the originator product. Once essential similarity is established, the two products in question are therapeutically equivalent and, as such, are interchangeable in treating patients with a given illness. See: bioequivalent.

Ester (as in “salts and esters”)

An ester is a chemical substance derived from an acid and an alcohol. The ester of the generic product must not affect its bioavailability. See: bioavailability; salt.

Evergreening

A term which describes techniques employed by pharmaceutical companies to take advantage of loopholes in the patent and regulatory systems to artificially extend the market monopoly of a product beyond its legitimate patent period. For more information and examples, see article on "Evergreening".

FDA

United States Food and Drug Administration

GCP

Good Clinical Practice

Generic medicine

Generic medicines are equivalent medicines demonstrating the same quality, safety and therapeutic efficacy as the originator product. They contain the same active substance under the same pharmaceutical form as the originator and are marketed after patent expiry. Generics are usually 20% to 90% less expensive than the originator, depending on national pricing policy and the pricing strategy of originators when facing price competition.

GMP - Good Manufacturing Practice

GMP ensures that pharmaceutical products are manufactured consistently and are controlled to the specific standards of quality set out in EU Directive 2003/94/EC. To be GMP certified, a company must show that its facilities and equipment are appropriate, its staff has the required levels of training, and that it manufactures according to approved procedures, maintains detailed manufacturing records, and follows EU norms on storage and transport.

HAI

Health Action International

Healthcare gap

The difference in spending on healthcare between wealthy countries and those which are less well-off. Average per capita spending on healthcare in the EU-15 amounts to approximately €1,600 per year, while in the 10 new Member States it amounts to only €400 per year. The savings from using generic medicines can help fill the €1,200 gap while ensuring quality medicinal treatment.

ICH

International Conference on Harmonisation

ICSR

Individual Case Safety Report

IGPA

International Generic Pharmaceutical Alliance

INN

International Non-proprietary Name. This is the scientific name used to identify a specific molecule used in pharmaceutical treatment. Generic medicnes are generally known by their INN rather than under a fantasy trade mark name.

JSG

Mutual Recognition Agreement Joint Sectional Group

Marketing Authorisation

A licence issued by a medicines agency approving the product for market based on a determination by the medicines agency that a pharmaceutical product meets the requirements of quality, safety and efficacy for human use in therapeutic treatment.

MA(H)

Marketing Authorisation (Holder)

Medicines agency

The national Member State or the European authority responsible for evaluating medicinal products, granting marketing authorisation and monitoring the safety of products through ongoing pharmacovigilance.

MINE

Medicines Information Network for Europe (EMEA initiative)

MRFG

CPMP Mutual Recognition Facilitation Group

MRP

Mutual Recognition Procedure, one of two routes currently available for authorising medicinal products for marketing in more than one country of the European Union. The MRP is available for most conventional medicines and consists of the marketing authorisation granted in one EU Member States being recognised as valid in other Member States upon request. The EMEA serves as arbitor in case of disputes between the concerned parties over the application. See: Centralised Procedure and Decentralised Procedure.

MSF

Médecins Sans Frontières (Doctors without Borders)

NCE

New Chemical Entity

NERA

National Economic Research Associates (company)

New indication

A therapeutic use for a pharmaceutical product which has been discovered and developed after the product’s initial marketing authorisation.

NGO

Non-governmental Organisation

NTA

Notice to Applicants

OMCL

The European Network of Official Medicines Control Laboratories

Originator medicinal product

The first version of a medicinal product, developed and patented by an originator pharmaceutical company which receives exclusive rights to marketing the product in the European Union for 15 years.

OTC

Over-the-Counter medicinal product, dispensed without prescription.

Patent

A document granting an inventor exclusive rights to exploit an invention for a given period of time in return for submiting to public access the complete information necessary to repeat the invention. The patent prohibits others from making, using or selling the invention without the permission of the inventor in the territory where the patent was issued, whilst enabling the advancement of knowledge through the publication of the technical and scientific details of the patented invention.

PECA

Protocol to the European agreement on Conformity assessment and Acceptance of industrial products

PES

Party of European Socialists (often seen in French: PSE)

Pharmacovigilance

The continuous monitoring of the safe use of medicinal products. Pharmacovigilance is generally regarded as all post-authorisaton scientific and data-gathering activities aimed at detecting, assessing, understanding, and preventing adverse events or reactions (ie, side-effects) or any other problems related to the use of a pharmaceutical product. This enables an ongoing assessment to ensure that only those medicines presenting a positive benefit-to-risk ratio remain in use.

PIC/S

Pharmaceutical Inspection Co-operation Scheme

Pricing & reimbursement system

The combined healthcare policies and mechanisms used by a government to set the prices of pharmaceutical products sold on its markets, and to determine under what conditions and to what levels the government will reimburse patients for the use of a given product.

PSUR

Periodic Safety Update Report

Reference product

The originator pharmaceutical product which is refered to in a generic medicine’s application for marketing authorisation.

Salt (as in “salts and esters”)

A salt is a chemical substance derived from the reaction between an acid and a base. Salts are commonly used in medicines. The particular salt form of a generic product must not affect its bioavailability. See: bioavailability; ester.

SANCO

European Commission DG responsible for public health and consumer affairs

Second medical use patent

A patent granted for a new use of a medicine that is discovered for a product that already possesses another pharmaceutical use. The new use can, for example, be a new indication or a new method of administering a medicine.

Similar biological medicinal product

Official term used by the competent authorities to refer to biosimilar products.

SmPC

Summary of Product Charactistics. The SmPC is a full, official description of a pharmaceutical product, which lists the name of the active substance, its composition, uses, dosages, pharmaceutical forms, and known adverse reactions, amongst other information. The SmPC is the basis of information for health professionals on how to use the medicinal product safely and effectively. The condensed version provided to patients with the medicine in the form of a “patient information leaflet” (PIL) must be written in language that is easily understood by non-professionals.

SOP

Standard Operating Procedure

SPC

Supplementary Protection Certificate. A regulatory measure (Council Regulation 1768/92/EEC) which extends the market exclusivity of patented pharmaceutical products for up to five additional years. SPCs are designed to guarantee 15 years of market exclusivity for originator products to compensate for long development periods.

SRM (TSE)

Specified Risk Material

TABD

Transatlantic Business Dialogue

TACD

Transatlantic Consumer Dialogue

TRIPs

Trade Related aspects of Intellectual Property

TSE

Transmissible Spongiform Encephalopathy

Usage patent / use patent

A patent that has been granted to a pharmaceutical company for a new use that is developed for a specified medicinal product. A new use can, for example, be for a new indication, a new target popoulation or a new mode of administration. See: new indication.

Well-established-use product

A medicinal product which has established a solid reputation of quality, safety and efficacy through at least 10 years of regular, documented therapeutic use in the European Union.

WHO

World Health Organisation

WTO

World Trade Organisation

WTO 30th of August Decision

This Decision implements Paragraph 6 of the Doha Declaration on Public Health. It will effectively allow developing countries with no pharmaceutical manufacturing capacity to import generic versions of patented products under compulsory licenses. It is essentially a temporary waiver until Article 31(f) of the WTO TRIPs agreement is amended in June 2004 by the TRIPs Council. Article 31(f) establishes that production under a compulsory license must be prodominently for the domestic market.


* In an effort to acheive both accuracy and clarity for the non-expert reader, the use of highly technical regulatory and legal jargon and phraseology has been limited in the glossary. This can, of course lead to an overly simplified expression of certain rather complex issues, perhaps at the expense of legal or scientific rigour. Should questions arise, the EGA would refer all interested parties to the appropriate legal texts, regulatory guidelines and scientific literature for more complete and precise definitions. One good source for definitions is the List of Standard Terms available at the Pharmeuropa Web site.
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