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Safety of medicinal
products in the EU

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all medicinal products...

...are authorised and monitored
in the European Union.

The European Commission along with EU/EEA national authorities and the European Medicines Agency (EMA) work together to ensure the SAFETY, HIGH QUALITY and EFFICACY of all medicinal products, before being placed on the market.

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To find out how
it all works, follow
THE LIFE
OF PILL

from the
clinical trial to
the use by a
patient.

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1. clinical trials

Clinical trials are conducted in order to test medicinal products for SAFETY and EFFICACY in humans. These are carried out by the medicine developers and are subject to specific EU legislation on Clinical Trials and to international standards.

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The European Commission ensures the highest standards of patient safety throughout these trials and creates an environment that is favourable for conducting them. For example:

  • An appropriately qualified me professional should be responsible for all the medical care provided to the subject.
  • The consent of the subject must be collected.
  • The Member State where the clinical trial will be conducted have to authorise the trial and can revoke or suspend the aurhorisation of a clinical trial, or require the that the trial is modified.
  • Member States should also be able to conduct inspections and should have adequate inspection capacities.

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The medicine developer can then submit the data obtained from clinical trials to request a marketing authorisation for a medicinal product.

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2. marketing authorisation

After going through clinical trials, all medicinal products must be authorised before they can be placed on the market. Authorisations are granted on the basis of the criteria of QUALITY, SAFETY and EFFICACY. There are several different routes of authorisation and one set of common EU rules.

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Applicants submit the marketing-authorisation application to the European Medicines Agency (EMA). The EMA then carries out a scientific assessment of the application and gives a recommendation to the Commission on whether to allow the product on the market.

CENTRALISED procedure

Applicants submit the marketing-authorisation application to the National Competent Authority of the Member States where they want to place the medicinal product.

MUTUAL-RECOGNITION procedure

DECENTRALISED procedure

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3. manufacturing

Once authorised, medicinal products can be mass produced. The manufacturing authorisation is granted by national competent authorities and entered into EudraGMDP, a publicly-available European database operated by the EMA.

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The "good manufacturing practices" (GMP) are a set of quality standards which ensure medicinal products are consistently safe and of high quality.

Manufacturers and importers of medicines to be marketed in the EU are inspected by national competent authorities to ensure compliance with good manufacturing practice.

Prior to being released on the market in the EU, medicinal products are controlled to ensure their quality.

  • The manufacturer should also have adequate premises and space; suitable equipment and services; correct materials, containers and labels and suitable storage and transport.
  • The manufacturer should have an adequate number of appropriately qualified and trained personnel with the necessary qualifications and practical experience.
  • Every person entering the manufacturing areas should wear protective garments appropriate to the operations to be carried out.

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4. Packaging

After manufacturing, the medicinal product must be packaged before being distributed to retailers and pharmacies throughout the EU.

All medicinal products placed on the market must have accessible and clear information on the labelling and package leaflet, so patients can use them safely and appropriately. The European Commission has developed guidelines to help manufacturers in the labelling and packaging of their products.

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Examples of guidelines for packaging and labelling:

  • The information presented on/within the package must be clear, legible, useful and easily understood.
  • The information given in the package leaflet must include the marketing authorisation number, the name of the medicinal product, its strength, the total content of the package, how to administer it, the expiry date and the target group it is intended for (non-exhaustive list).
  • There should also be information regarding the safe use of the product, for some medicinal products additional information is needed.
  • Child resistant packaging should also be used in certain cases when the medicinal product contains certain kinds and/or quantities of particular substances.

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This medicinal product is subject to additional monitoring.

The EU has introduced special labelling for medicinal products that are being monitored particularly closely by regulatory authorities. Medicinal products “under additional monitoring” have a black inverted triangle displayed on their package leaflet. This is generally because there is less information available on them than on other products, for example because they are new to the market or there is limited data on their long-term use.

It does not mean that the medicinal product is unsafe.

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5. Distribution

Once properly packaged, medicinal products are ready for distribution, an increasingly complex process involving many players. To support distributors in this process, the European Commission developed the ‘good distribution practices’ (GDP) which cover the various stages of the distribution process including handling, transportation and storage.

Distributors must follow certain procedures to protect medicinal products against breakage, adulteration and theft as well as from harmful effects of light, temperature, moisture and other external factors.


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Examples of guidelines for distribution:

  • Medicinal products should be stored separately from other products likely to alter them and should be protected from the harmful effects of light, temperature, moisture and other external factors.
  • Medicinal products should be handled and stored in such a way to prevent spillage, breakage, contamination and mix-ups.
  • Distributors should ensure that all vehicles and equipment used to distribute, store or handle the medicinal products are suitable for their use and appropriately equipped.
  • Procedures for investigating and handling damages should be set out. If, for example, during transportation a medicinal product is damaged, this should be reported immediately to the distributor as well as to the recipient of the affected product.

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6. Retailers

Once the product has safely arrived at the licensed retailer or pharmacy and is being stored safely according to the 'good distribution practices', the product is ready to be sold to the general public.

Member States are responsible for determining who can sell medicinal products to the public.

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The illegal sale of medicinal products to the public via the Internet by retailers operating outside the law is a serious danger, as falsified medicinal products may easily reach the public in this way. For this reason the EU has introduced a common logo for legally operating online pharmacies/retailers in Member States.

The logo will help identify the websites which are operating legally: the purchaser clicks on the logo and is redirected to the website of their national authority which contains the list of legally operating on-line pharmacies and retailers. Buying from a legally operating pharmacy or retailer guarantees the safety of the products.

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7. Advertising

Before medicinal products can be advertised, Member States must ensure that they have a marketing authorisation. Member States should have effective methods in place to monitor the advertising of medicinal products. The medicine developer must provide the monitoring authorities in their Member State with a sample of all advertisements. Medicinal products which are prescription only cannot be advertised to the general public.

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Examples of legal requirements for advertising:

  • Member States cannot ban, on their territory, advertising to the general public of the medicinal product the cost of which may be reimbursed;
  • The advertising:
    • Must encourage the rational use of the medicinal product, by presenting it objectively and without exaggerating its properties.
    • Must not be misleading.
    • All advertising to the general public of a medicinal product must be clearly identifiable and give the name of the product, how to use it correctly and a specific and legible invitation to read the instructions carefully.

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8. Pharmacovigilance

Once the medicinal product is on the market, healthcare professionals monitor and receive feedback from their patients on any adverse reactions.

All suspected serious side effects that are reported by patients and healthcare professionals must be entered into EudraVigilance, a web-based information system designed to manage information on safety reports. This data is monitored to identify new safety related information.

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9. Falsified medicinal products

These are fake medicinal products that pass themselves off as the real thing. Falsified products may contain ingredients which are of bad quality or in the wrong dose – either too high or too low, or even no active ingredients at all. Therefore they could be harmful to a patient’s health.

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As falsifications become more sophisticated, the risk that falsified medicinal products reach patients in the EU increases every year. The EU has put provisions in place to combat this, for example:

  • The common, EU-wide logo to identify legal online retailers of medicinal products which makes it easy to distinguish between legal and illegal online retailers of medicinal products throughout the European Union.
  • Strengthened record-keeping requirements for wholesale distributors.
  • Tougher rules on the controls and inspections of producers of active pharmaceutical ingredients.

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…and that’s how medicinal products are kept safe in the EU!

For more information, visit www.ec.europa.eu/health/EUpharma50