Terminology and References

Terms and acronyms

ADRAdverse Drug Reaction. From  Wikipedia: An adverse drug reaction (abbreviated ADR) is an expression that describes harm associated with the use of given medications at a normal dose. The meaning of this expression differs from the meaning of "side effect", as this last expression might also imply that the effects can be beneficial. The study of ADRs is the concern of the field known as  pharmacovigilance.
DDIDrug-Drug Interaction.
EPARThe European Public Assessment Report (EPAR) reflects the scientific conclusion reached by the  EMEA Committee for Medicinal Products for Human Use (CHMP) at the end of the centralised evaluation process. The legal basis for its creation and availability is contained in Article 13(3) of Regulation (EC) No 726/2004. It is made available by the EMEA for information to the public, after deletion of commercially confidential information. The EPAR provides a summary of the grounds for the CHMP opinion in favour of granting a marketing authorisation for a specific medicinal product. It results from the Committee's review of the documentation submitted by the applicant, and from subsequent discussions held during CHMP meetings. The EPAR is updated throughout the authorisation period as changes to the original terms and conditions of the authorisation (i.e. variations, pharmacovigilance issues, specific obligations) are made. EPARs also contain a summary written in a manner that is understandable to the public.
PILPatient Information Leaflet. A PIL is the leaflet that is included in the pack with a medicine. The PIL is written by the pharmaceutical company and is a patient-friendly version of the Summary of Product Characteristics. All PILs are checked and approved by the UK or European medicines licensing agency. If you are unsure about anything or have any questions about the PIL, always speak to a healthcare professional such as a doctor, pharmacist or nurse.
RECInformal abbreviation used in drugle project for "recommended drug". Used for sources like Kloka Listan.
SPCSummary of Product Characteristics. The SPC is used by healthcare professionals, such as doctors, nurses and pharmacists, and explains how to use and prescribe a medicine. SPCs are written and updated by pharmaceutical companies and are based on their research and product knowledge. The SPC is then checked and approved by the UK or European medicines licensing agency. SPCs have to contain certain numbered headings and information. We now explain, in simple terms, what the headings mean and what each section contains.
Mutual RecognitionThe mutual recognition procedure is based on that medicines are evaluated and approved by a Reference Member State (RMS) followed by a 90-day period where the Concerned Member States (CMS) consider the RMS assessment report. If the CMS agree with the assessment they should issue a marketing authorisation within 120 days from the start of the procedure. If the CMS does not agree with the RMS decision they can refer the application to arbitration, the Committee for Proprietary Medicinal Products (CPMP) at the European Medicines Evaluation Agency (EMEA) will handle the arbitration.
90 Day procedureIn order to manage the 90 day procedure the Members States operate a tracking system, Eudratrack, where the RMS updates the product information. All events during the 90 days period are updated by the RMS and CMS. After a procedure has been finalised and the product has been accepted at day 90 by the CMS the product will be transferred, at day 120, from the tracking system into the Product Index This is the date when,all Member States involved in the procedure should have granted a marketing authorisation. In some cases, the marketing authorisation in a particular member state could be delayed until after day 120 and thus the product will not be on the market in that Member State. Questions in such a case should be put to the marketing authorisation holder or to that member state's competent authority.

Symbols and color conventions

Inverted Black TriangleFrom  EMC. Some Summaries of Product Characteristics have an inverted black triangle symbol displayed at the top of the document and next to medicine name. This symbol shows that the medicine is being intensively monitored by the  Commission on Human Medicines (CHM), probably because it is new or is being used to treat new medical conditions. The black triangle is removed by the CHM when the safety of the medicine is well established.

References and data sources

Site/Organization/Data? sourceDescription
AESAgencia Española de Medicamentos y Productos Sanitarios (ES).
Link:  http://www.agemed.es
EMEAEuropean Medicines Agencey (EU).
Link:  http://www.emea.europa.eu
MedDRAMedical Dictionary for Regulatory Activities. It is a pragmatic, medically valid terminology with an emphasis on ease of use for data entry, retrieval, analysis, and display, as well as a suitable balance between sensitivity and specificity within the regulatory environment. It was developed by the International Conference on Harmonisation (ICH) and is owned by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) acting as trustee for the ICH steering committee.
Link:  http://www.meddramsso.com/MSSOWeb/index.htm
MHRAMedicines and Healthcare products Regulatory Agency (UK).
Linke:  http://www.mhra.gov.uk
PubMedPubMed comprises more than 19 million citations for biomedical articles from MEDLINE and life science journals back to 1948. PubMed includes links to full-text articles which may be found in other databases such as PubMed Central or at publisher web sites.
Link:  http://www.ncbi.nlm.nih.gov/pubmed/
HMAThe Heads of Medicines Agencies is a network of the Heads of the National Competent Authorities whose organisations are responsible for the regulation of Medicinal Products for human and veterinary use in the European Economic Area. The Heads of Medicines Agencies is supported by working groups covering specific areas of responsibility and by the Heads of Medicines Agencies Management Group and Permanent Secretariat.
Mantainer of the MRI - Product Index (Mutual Recognition Index)
Link:  http://www.hma.eu
Danish Medicine Agency
(Lægemiddel Styrelsen)
Link:  http://www.dkma.dk

SPCs in:  http://www.produktresume.dk
Multilingual Glossary of technical and popular medical terms in nine European Languages (Robert Van der Stichele - Ghent University)
Link:  http://users.ugent.be/~rvdstich/eugloss/welcome.html