1. Quality of the medicinal products. Drug switching.
Social Pharmacy - Lecture 09 Authorisation of medicinal products (in the EU). Institutional framework. Authorisation procedures.
Quality of the medicinal products.
Drug switching.
JAMASOFT2017

2. JAMASOFT2017

3. To guarantee the highest possible level of public health
and to secure the availability of medicinal products to citizens across the EU, all medicinal products for human use have to be authorised either at Member State or Community level before they can be placed on the EU market.
JAMASOFT2017

4. The authorisation is based on the evaluation
of the
quality,
safety
and efficacy
of the medicinal product
and the assessment of its benefit and risk.
JAMASOFT2017

5. The particulars and documents
which must accompany an
application for the authorisation for a medicinal product
demonstrate that potential risks are outweighed by the therapeutic efficacy of
the product.
JAMASOFT2017

6. Competent authorities to grant an authorisation in the EU are
national governmental institutions „medicines agencies“ and
2. the European Commission (decision making) in collaboration and shared responsibility with the European Medicines Agency (application and documentation evaluation).
JAMASOFT2017

7. Authorisation of medicinal products in the EU
Main stakeholders in the process are
- patients and consumers,
- healthcare professionals,
- healthcare providers, payers
(insurance companies) and
- applicants (pharmaceutical
companies).
JAMASOFT2017

8. The pharmaceutical industry
makes an important contribution to Europe's and the world's well-being. It is a strategic sector due to its economic as well as its public health dimension.
JAMASOFT2017

9. Life cycle of a medicinal product:
Research and development,
Manufacturing
Authorisation application: benefit-risk
Obligations of the authorisation holder
Post-marketing surveillance: quality and safety
(pharmacovigilance)
Variations in the authorisation
Validity of the authorisation and renewal
JAMASOFT2017

10. JAMASOFT2017

11. JAMASOFT2017

12. The authorisation procedures
The European system for the authorisation of medicinal products for human and animal use was introduced in January 1995 with the objective of ensuring that safe, effective and high quality medicines could quickly be made available to citizens across the European Union.
JAMASOFT2017

13. EMA
JAMASOFT2017

14. The European Medicines Agency
is a decentralised agency of the European Union, located in London. The Agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union.
JAMASOFT2017

15. centralised procedure decentralised procedure
The European system offers several routes for the authorisation of medicinal products:
centralised procedure
decentralised procedure
mutual recognition procedure
purely national procedure (one member state only)
JAMASOFT2017

16. The Centralised Procedure.
Applications for the centralized procedure are made directly to the European Medicines Agency which issues and Opinion resulting from the scientific assessment
of the quality, safety and efficacy of medicinal products and further may lead to the granting of an European marketing authorisation by the Commission which is binding
in all Member States.
JAMASOFT2017

17. The Decentralised Procedure
which was introduced with the
legislative review of 2004, is also applicable to the majority of conventional medicinal products. Through this procedure an application for the marketing authorisation of a medicinal product is submitted simultaneously in several Member States, one of them being chosen as the "Reference Member State".
At the end of the procedure national authorisations are granted in the reference and in the concerned Member States.
JAMASOFT2017

18. The Mutual Recognition Procedure
which is applicable to the majority of conventional medicinal products, is based on the principle of recognition of an already existing national authorisation by one or more Member States.
JAMASOFT2017

19. Special rules exist for
the authorisation of medicinal products for paediatric use, orphan drugs, advanced therapy, traditional herbal medicinal products, vaccines, homeopathics.
JAMASOFT2017

20. A homeopathic medicinal product.
Only homeopathic medicinal products which satisfy all of the following conditions
may be subject to a special, simplified registration procedure:
administered orally or externally no specific therapeutic indication appears on the labelling
there is a sufficient degree of dilution
to guarantee the safety of the medicinal product.
JAMASOFT2017

21. Authorisation procedures.
The national authority closely examines the efficacy, risks and quality of the medicine. All important data about the medicine is reproduced in the detailed product information sheet for doctors and pharmacists (summary of product characteristics, SPC). A summary for patients is also made, in the form of a package leaflet. The national authority also decides on the product's legal status. (whether it can be obtained without prescription or may only be dispensed on prescription).
JAMASOFT2017

22. Once a medicine has been marketed,
the national authority
continues to monitor the medicine‘s
Adverse Event Reports.
It therefore always contains the most up-to-date information about the efficacy and possible adverse events of medicines.
If necessary, the authority can take steps like modifying the package leaflet text or in the most extreme case - suspending sales or even withdrawing the medicine from the market entirely.
JAMASOFT2017

23. The authorisation shall be refused,
if it is clear that:
(a) the risk-benefit balance is not considered to be favourable, or
(b) its therapeutic efficacy is insufficiently substantiated by the applicant, or
(c) its qualitative and quantitative composition is not as declared.
JAMASOFT2017

24. Medicinal product information is an integral part of the authorisation!
Information intended for healthcare professionals,
ongoing harmonisation in the EU therapeutic indications,
posology and methods of administration,
contra-indications,
special warnings and precautions for use,
interactions with other medicinal products,
use during pregnancy and lactation,
effects on ability to drive and to use machines
undesirable effects,
overdose,
pharmacological (pharmacodynamic, pharmacokinetic) properties,
preclinical safety data,
pharmaceutical particulars.
JAMASOFT2017

25. The official contents of Summary of Product Characteristics (SPC):
1. Name of the medicinal product
2. Qualitative and quantitative composition
3. Pharmaceutical form
4. Clinical particulars
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Fertility, pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. Pharmacological properties
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. Pharmaceutical particulars
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. Marketing authorisation holder
8. Marketing authorisation number(s)
9. Date of first authorisation/renewal of the authorisation
10. Date of revision of the text
JAMASOFT2017

26. Patient information leaflet (PIL) Braille
Medicinal product information as an integral part of the authorisation.
Patient information leaflet (PIL)
Braille
Challenges of multilingual texts
JAMASOFT2017

27. Quality of the medicinal product.
The application shall be accompanied by the following
particulars and documents:
- description of the manufacturing method,
- description of the control methods employed by the manufacturer,
- a document showing that the manufacturer is authorised in his own country to produce medicinal products.
JAMASOFT2017

28. Quality of the medicinal product
Member States shall take all appropriate measures to ensure that:
(a) the competent authorities verify that manufacturers and importers of medicinal products coming from third countries are able to carry out manufacture in compliance
(b) the competent authorities may allow manufacturers and importers of medicinal products coming from third countries, in justifiable cases, to have certain stages of manufacture and/or certain of the controls referred to in (a) carried out by third parties; in such cases, the verifications by the competent authorities shall also be made in the establishment designated.
JAMASOFT2017

29. Good Manufacturing Practice (GMP) is defined as
„That part of Quality Assurance which ensures that products are
consistently produced and controlled to the quality
standards appropriate to their intended use.“
The competent authority may also carry out unannounced
inspections at the premises of manufacturers of active
substances used as starting materials, or at the premises
of the authorization holders whenever it considers that there are grounds for suspecting noncompliance with
the principles and guidelines
of Good Manufacturing Practice.
JAMASOFT2017

30. Authorisation and Switching of Medicine-Status:
from Prescription-only To Over-the-counter availability.
JAMASOFT2017

31. In order to market
a medicinal product a manufacturer must first obtain regulatory approval by conducting clinical tests and trials to prove that the product is safe and effective.
JAMASOFT2017

32. Producers of generic medicines
are able to use the original manufacturer's approval if they can demonstrate, that the generic version is bioequivalent to the approved medicine.
JAMASOFT2017

33. Facilitating generic drug manufacturing. Drug Switching.
As the global disease burden expands, the need for new, more effective treatments is greater than ever. Investing in drug research and development is, however, a costly, high-risk endeavor. Patents are intended to offer some guarantee of a return on investment, but the patent system is also designed to balance the interests of inventors with those of the public. After a patent expires, a patented technology may be freely exploited by anyone. Drug switching refers to the practice of replacing a brand name drug with a generic drug. This practice is often used to reduce drug costs.
JAMASOFT2017

34. Facilitating generic drug manufacturing: Bolar Exemptions Worldwide.
To overcome this problem, many countries have put into place legal exemptions (or research exemptions) from infringement for certain acts relating to the development and submission of testing data to a regulatory agency. These exemptions are often referred to as “Bolar” exemption.
JAMASOFT2017

35. In patent law,
there is an exemption to the rights conferred by patents, which is especially relevant to drugs.
JAMASOFT2017

36. Facilitating generic drug manufacturing: Bolar exemptions worldwide.
Within Europe, there exists a defence to patent infringement commonly referred to as the “Bolar” exemption, which applies to acts legitimately undertaken for the regulatory approval of medicinal products. Many nations have put similar exemptions in place, but their nature and scope vary significantly from country to country.
JAMASOFT2017

37. The Bolar exemption
was a small part of a comprehensive reform of the current European Union pharmaceutical legislation proposed by the European Commission in July 2001.
JAMASOFT2017

38. Authorisation of Medicinal Products and Switching of Medicine-Status.
Prescription medicines are increasingly being switched to over-the-counter (OTC, nonprescription) status in the developed world, with the support of government policy.
JAMASOFT2017

39. Thanks for your attention.
JAMASOFT2017