Use the Lexology Navigator tool to compare the answers in this article with those from other jurisdictions. 

Trends and developments

Legal developments

Are there any notable trends or recent legal developments in your jurisdiction’s pharmaceutical industry?

No.

Legal framework

Legislation

What is the primary legislation governing medicinal products in your jurisdiction?

The main legislation governing medicinal products in Luxembourg is as follows:

  • the Act of 4 August 1975 on the manufacturing and importation of medicinal products (as amended);
  • the Act of 25 November 1975 on the issuance of medicinal products to the public (as amended);
  • the Act of 11 April 1983 on the regulation of placing on the market and advertising of pharmaceutical specialties and prefabricated medicinal products (as amended);
  • the Grand Ducal Regulation of 15 December 1992 on the placing on the market of medicinal products (as amended);
  • the Grand Ducal Regulation of 19 November 2004 on the manufacturing of medicinal products, the good manufacturing practices for medicinal products and the good manufacturing practices for experimental medicinal products for human use (as amended);
  • the Grand Ducal Regulation of 30 May 2005 on the application of good clinical practice in conducting clinical trials of medicinal products for human use (Modified RGD 30 May 2005); and
  • the Grand Ducal Regulation of 26 September 2006 amending:
    • the amended Grand Ducal Regulation of 15 December 1992;
    • the amended Grand Ducal Regulation of 15 January 1993 on the placing on the market of veterinary medicinal products; and
    • the Grand Ducal Regulation of 19 November 2004.

Are any legislative changes proposed or expected in the near future?

The European Commission will continue to support member states’ implementation of the EU Falsified Medicines Directive (2011/62/EU); in particular, the medicine authentication system, which will apply to EU member states (including Luxembourg) in February 2019.

As a new parliament was elected on 14 October 2018 and a new government formed, it is impossible to predict any legislative developments in the near future.

Regulation

Which bodies regulate medicinal products in your jurisdiction and what is the scope of their powers?

The Ministry of Health and the Ministry of Social Security regulate medicinal products in Luxembourg.

The Ministry of Health is responsible for:

  • defining and implementing the government's health policy;
  • overseeing the application of health laws and regulations; and
  • overseeing health institutions and services.

The Pharmacy and Medication Department is part of the National Health Directorate under the authority of the Ministry of Health and has authority over all questions relating to medicinal and pharmaceutical products and related professions in the public and private sectors. It notably controls the manufacturing, marketing, advertising, distribution, import and export of these products.

Its authority also extends to:

  • drug precursors;
  • narcotics and psychotropics;
  • veterinary medicinal products;
  • cosmetic and hygienic products; and
  • genetically modified organisms.

The Pharmacy and Medication Department carries out inspections to make sure that the distribution sites are compliant with the requirements of good practices. Certificates of good distribution practices and wholesale trade authorisations are delivered as appropriate by the Ministry of Health.

In the context of international trade, the Pharmacy and Medication Department verifies the marketing conditions of the products that it monitors and delivers, as appropriate, import and export authorisations on a case-by-case basis (eg, drug precursors, narcotics and psychotropics).

The Ministry of Social Security is primarily tasked with monitoring and coordinating the social security system operated by public administrations (eg, health insurance and pension funds) and primarily aims to provide insurance benefits to cover:

  • illness;
  • accidents;
  • dependency;
  • old age; and
  • the death of:
    • a spouse; or
    • the parent of a minor.

Are any other legal regimes applicable to the trade of medicinal products (eg, competition, international trade, data protection, consumer protection)?

Yes.

In principle, prices are set by free market competition. However, the executive branch of the government can regulate prices under certain circumstances or in certain sectors (eg, the pharmaceutical industry) if the price competition is insufficient. The legal reference on this matter is the Competition Act of 23 October 2011.

On 16 August 2018 the government adopted and published the Act of 1 August 2018 on the organisation of the National Commission for Data Protection and implementing the EU General Data Protection Regulation (2016/679).

This new law applies to special categories of data by the health services as follows:

  • data on health and sex life necessary for the purpose of preventative medicine, medical diagnosis or the provision of care or treatment;
  • data on health and sex life necessary for the purpose of healthcare or scientific research; and
  • data on health and sex life necessary for the management of healthcare services.

Are any medicinal products exempt from regulation (eg, complementary and alternative medicines)?

No, except in case of emergency medicine or epidemic.

Supply

Manufacture

What is the authorisation procedure for the manufacture of medicinal products in your jurisdiction?

The manufacture of medicinal products is subject to prior authorisation issued by the Ministry of Health.

A company that exports medicinal products must hold a wholesale distribution authorisation or a manufacturing authorisation. These products do not require a marketing authorisation under European law; however, the exporter must comply with the legal provisions of the destination country.

A company that manufactures medicinal products must have a manufacture authorisation even if the product is manufactured for export.

A company that imports a medicinal product from a third country must have a manufacture and import authorisation.

To supply manufacture and import authorisations, the Pharmacy and Medication Department carries out:

  • inspections to verify compliance with good manufacturing practices; and
  • for imports from a third country, a compliant batch release according to the same principles.

The application for an authorisation is subject to an investigation and a report drawn up by a civil servant pharmacist of the pharmacies inspectorate. Manufacture and import authorisations may then be granted by the Ministry of Health.

What is the fee for obtaining authorisation?

There is no fee for obtaining such authorisation.

What is the validity period for authorisation?

The validity period for a manufacturing authorisation is unlimited except in special cases where a temporary authorisation is granted.

How robust are the standard good manufacturing practices followed in your jurisdiction?

The standard good manufacturing practices of the European Union apply in Luxembourg.

What are the consequences of failure to obtain manufacturing authorisation and/or follow good manufacturing practices?

Failure to obtain a manufacturing authorisation prevents the manufacturing of the corresponding medicinal product in Luxembourg.

Distribution

How are the distribution and storage of medicinal products regulated?

In order to fight against the release or circulation of counterfeit medicinal products, the trade of medicinal products is strictly monitored.

The Pharmacy and Medication Department, which is part of the National Health Directorate under the authority of the Ministry of Health, insures that only medicinal products for which a marketing authorisation has been issued in compliance with Community law are distributed in Luxembourg. It controls the persons authorised to exercise the wholesale trade of medicinal products and inspects their premises.

The company in charge of the transport, storage, handling of medicinal products for human use must possess:

  • a manufacture and import authorisation;
  • a wholesale trade authorisation; or
  • a certificate of good distribution practices delivered by the Luxembourg ministry or a competent national authority in another country.

Import and export

How are the import and export of medicinal products regulated?

A medicinal product with a marketing authorisation may be circulated freely within the European Union.

The transport, storage and handling of medicinal products for human and veterinary uses are subject to strict rules known as good distribution practices. These practices must be carried out in appropriate conditions defined in the marketing authorisations or other specifications directly relating to the products in question.

European regulations define the good distribution practices for the wholesale distribution of medicinal products for human use, in particular the conditions of temperature and storage during transport, as well as the rules governing packaging and labelling.

The only organisations that may carry out the activities described above are:

  • holders of manufacture and import authorisations;
  • holders of wholesale trade authorisations of medicinal products; and
  • holders of certificates of good distribution practices.

A company that exports medicinal products must hold a wholesale distribution authorisation or a manufacture authorisation. These medicinal products do not need a marketing authorisation under European law; however, the exporter must comply with the legal provisions of the destination country.

A company that manufactures medicinal products must have a manufacture authorisation even if the product is manufactured for export.

A company that imports a medicinal product from a third country must have a manufacture and import authorisation.

To deliver a manufacture and import authorisation, the Pharmacy and Medication Department carries out:

  • inspections to verify the compliance with good manufacturing practices; and
  • for imports from a third country, a compliant batch release according to the same principles.

A manufacture and import authorisation can then be delivered by the Ministry of Health.

Are parallel imports permitted in your jurisdiction?

This commercial practice is legalised within the EU market by virtue of the principle of free movement of goods. It was recognised by the European Court of Justice in 1976.

These parallel imports do not require the prior consent of the manufacturer, but may be restricted in certain specific cases (eg, when they affect the protection of human health and life, as well as the protection of industrial and commercial property).

Sale and purchase

What rules govern the dispensing, sale and purchase of medicinal products?

The Act of 25 November 1975 on the issuance of medicinal products to the public (as amended).

Are there any restrictions on the online sale and purchase of medicinal products?

Online sales are reserved for pharmacists operating a pharmacy and having previously notified the ministry with the information requested by the Article 3ter of the Act on the issuance of medicinal products to the public of 25 November 1975 (as amended).

Named patient supply

What rules govern named patient supply of pre-launch medicinal products?

Compassionate use programmes are coordinated and implemented by EU member states, which set their own rules and procedures.

These programmes are put in place only if the medicinal product is expected to help patients with life-threatening, long-lasting or seriously debilitating illnesses which cannot be treated satisfactorily with any currently authorised medical product.

The medicinal product must be undergoing clinical trials or have entered the marketing authorisation application process and while early studies will generally have been completed, its safety profile and dosage guidelines may not be fully established.

In practice, physicians fill out a specific form indicating the compassionate use they wish to administer to their patient, which they send to the Ministry of Health. Generally, the ministry grants compassionate use for a period of six months.

Clinical trials

Authorisation

What is the authorisation procedure for conducting clinical trials in your jurisdiction?

Article 25 of the Hospital Act of 28 August 1998 states that no trial, study or experimentation can be done on a human being with the aim of furthering knowledge in the fields of biological and medical sciences if the project has not first been submitted to the approval of a research ethics committee.

Chapter 5 (Articles 76-79) of the Medical Deontology Code, approved by the Ministerial Decree of 1 March 2013, relates to human experimentation and in particular states that any protocol, whether it is done in a hospital context or not, must have authorisation. The trial can start only after the delivery of a positive opinion from the research ethics committee and after the implicit or explicit approval of the Health Ministry, in agreement with the legal and regulatory requirements that are to be applied in the matter.

Approximately 113 clinical studies are being or have been conducted in Luxembourg. The country of the clinical trial is determined by the location where the clinical research is being studied. Most studies are held in multiple locations and countries.

Clinical practices

How robust are the standard good clinical practices followed in your jurisdiction?

The EU standard good clinical practices apply in Luxembourg.

Reporting, disclosure and consent

What are the reporting and disclosure requirements for the results of clinical trials?

The documentation relating to a clinical trial that constitutes the permanent record of the trial includes the essential documents that make it possible to evaluate the completion of the clinical trial and the quality of the data provided.

The investigator immediately notifies the sponsor of all serious adverse events. These notifications are followed by detailed written reports.

More information is provided in the Grand Ducal Regulation of 30 May 2005 on the application of good clinical practice in conducting clinical trials of medicinal products for human use (Modified RGD 30 May 2005).

What are the informed consent obligations with respect to clinical trial subjects?

Informed consent implies a decision, which must be written, dated and signed, to take part in a clinical trial, taken freely after being duly informed of the nature, significance, implications and risks and appropriately documented, by any person capable of giving consent or, where the person is incapable of giving consent, by their legal representative; if the person concerned is unable to write, oral consent in the presence of at least one witness may be given in exceptional cases, as provided for in national legislation.

Templates for informed consent forms (available in French, German and English) are provided on the National Research Ethics Committee website under “Procedures > Submission of a new study”.

Further requirements on granting consent, particularly regarding vulnerable populations, are specified in Articles 3 to 5 of the Grand Ducal Regulation of 30 May 2005 on the application of good clinical practice in conducting clinical trials of medicinal products for human use (Modified RGD 30 May 2005).

Insurance

What are the insurance requirements for clinical trials?

Provisions for insurance or indemnity to cover the liability of the investigator and sponsor are mandatory.

According to Article 25 of Hospital Act of 28 August 1998, the sponsor and investor must subscribe an insurance covering their responsibility, as well as the responsibility of all the persons involved.

Study insurance covers the risks to patients during their participation in the trial. In case of malpractice and non-conformity to the protocol, the insurance might of course turn against the physician. Physicians in Luxembourg are responsible for having liability insurance and checking whether it covers malpractice.

Essential documents are kept by the investor and sponsor for at least five years after the end of the study. The documents are kept longer if required by applicable requirements or agreement between investigator and sponsor.

Data protection

What data protection issues should be considered when conducting clinical trials?

Notification to the data protection authority or ombudsmann is mandatory.

Generally, research projects involving human subjects also must be notified to or authorised by the National Data Protection Commission (CNPD).

Notification forms (in French and German) are available on the CNPD website.

Obligations to prior authorisation and related requirements are now specified in Act of 1 August 2018 on the organisation of the National Commission for Data Protection and implementing the EU General Data Protection Regulation (2016/679).

Marketing authorisation

Authorisation

What is the marketing authorisation procedure for medicinal products in your jurisdiction?

With a view to granting a marketing authorisation for a medicinal product, the person responsible for placing the product on the market must lodge an application to the Ministry of Health.

This application must be accompanied by the information and documents specified in Article 1 of Grand Ducal Regulation of 15 December 1992 on the placing on the market of medicinal products (as amended).

What criteria are considered in granting marketing authorisation?

When a company applies for a marketing authorisation in Luxembourg, it has often applied for and obtained a marketing authorisation in another European Economic Community (ECC) member state (the reference member state) and Luxembourgish authorities check only the work already done by the authorities of this country and generally follow its decision by granting a marketing authorisation in Luxembourg (the consent member state).

What is the fee for obtaining marketing authorisation?

The Act of 19 December 2014 on the implementation of the future package introduced a series of new taxes on medical products applicable from 1 January 2015, including taxes on:

  • national applications if a marketing authorisation in another ECC member state already exist cost €600, to be paid prior to the application; and
  • national applications if no marketing authorisation in any ECC member state exists cost €12,500, to be paid prior to the application.

What is the validity period for marketing authorisation?

The validity period for marketing authorisation is five years renewable by five-year period at the request of the holder in the three months preceding the due date (see Article 9 of the Amended Act of 11 April 1983 on the regulation of placing on the market and advertising of pharmaceutical specialties and prefabricated medicinal products). The annual fee to maintain marketing authorisations is €100 and applications for renewing a marketing authorisation costs €600, to be paid prior to the application.

What are the consequences of failure to obtain marketing authorisation?

In order for a medicinal product to be marketed in Luxembourg, it must:

  • possess a marketing authorisation valid in Luxembourg issued by the Ministry of Health; and
  • have a public price attributed by the Ministry of Social Security.

Therefore, failure to obtain marketing authorisation prevents the sale, detention for sale, free transfer and import of the corresponding medicinal product in Luxembourg.

Pharmacovigilance

Monitoring

What post-market monitoring mechanisms are in place to ensure the ongoing safety and efficacy of medicinal products after marketing authorisation has been granted?

The Ministry of Heath has a pharmacovigilance service that hears complaints for defective medicinal products. Such complaints can be filed by anybody.

The ministry suspends or withdraws the marketing authorisation of a medicinal product when it appears that:

  • the medicinal product is harmful under normal conditions of use;
  • the therapeutic effect is lacking; or
  • the medicinal product does not have the declared qualitative or quantitative composition.

The Ministry of Health appoints an expert commission whose mission is to provide reasoned opinions on applications for marketing authorisation of medicinal products and, if appropriate, submit proposals for suspension or withdrawal of such marketing authorisations.

Data protection

What data protection issues should be considered when conducting pharmacovigilance activities?

All data protection requirements are now specified in the Act of 1 August 2018 on the organisation of the National Commission for Data Protection and implementing the EU General Data Protection Regulation (2016/679).

Pricing and reimbursement

Pricing

Are there rules governing the pricing of medicinal products in your jurisdiction?

Yes – see Grand Ducal Regulation of 1 December 2011 on the criteria, conditions and procedure for the pricing of medicinal products for human use (as modified).

In Luxembourg, the minister in charge of social security policy decides on prices for all products which are considered and defined as ‘medicinal products’.

A request should be filed to the Ministry of Social Security via a form to fill out specifying the official prices in the country of origin and the prices requested in Luxembourg.

Marketing authorisation holders are authorised to commercialise a product only after having received the approval of the price by the minister.

As most products covered by health insurance are imported from Belgium, the public prices practiced in Luxembourg are directly derived from Belgian retail prices.

Reimbursement

What is the structure for state reimbursement of medicinal product costs?

In principle there is no relationship between pricing and reimbursement. However, in practice, the Ministry of Social Security sets out a positive list and, based on this list, the National Health Fund will decide whether to reimburse. The normal rate of reimbursement in Luxembourg is 80% of the public price. The healthcare system works on a reimbursement basis whereby you submit receipts for consultations, treatment and medicines to the National Health Fund for reimbursement at the appropriate rate, which varies between 80% to 100%.

Since 1 October 2014, pharmacists must inform their patients that a generic drug is on the market. The generic product is substitutable and belongs to a group of alternative drugs. The substitutable drugs are listed by the National Health Directorate. Based on this list, the National Health Fund fixes for all alternative products the basis of reimbursement and set reference amount on which the participation of the patient is established. If the patient refuses the generic product, they must pay the difference that is not supported by the National Health Fund.

The list of all the groups of medicinal products subjected to a reimbursement is published in the Official Journal (www.legilux.lu).

Advertising and labelling

Advertising

How is the advertising of medicinal products to healthcare professionals and the general public regulated in your jurisdiction?

The advertising of medicinal products to healthcare professionals and the general public is regulated by the Grand Ducal Regulation of 15 December 1992 relating to the placing on the market of medicinal products, which transposes into national law part of EU Directive 92/28 /EEC of 31 March 1992 concerning the advertising of medicinal products for human use.

The general principles are set out in Article 18 of the regulation – for instance:

  • Any advertising made in respect of a medicinal product for which a marketing authorisation has not been issued by the Ministry of Health is prohibited.
  • All elements of a drug advertisement must comply with the information provided in the summary of product characteristics.

Do any special rules apply to online advertising of medicinal products?

No, the same provisions apply for online advertising of medicinal products.

Labelling

What are the packaging and labelling requirements for medicinal products?

The outer packaging or, in the absence of outer packaging, the primary packaging of any medicinal product must bear the particulars specified in Article 10 of the Grand Ducal Regulation of 15 December 1992 on the placing on the market of medicinal products (as amended).

For instance, it must include the following information:

  • the name of the medicinal product;
  • the qualitative and quantitative composition of active ingredients per dosage unit or, depending on the form of administration, for a given volume or weight, using the common names;
  • the pharmaceutical form and the content by weight, volume or units of catches;
  • a list of excipients which have a known action or effect;
  • the mode of administration and if necessary the route of administration;
  • a special warning;
  • the expiry date (month and year);
  • special precautions for storage, if applicable;
  • the name and address of the marketing authorisation holder;
  • the number of the marketing authorisation; and
  • the batch number.

For experimental drugs, the labelling must:

  • guarantee the protection of the user and the traceability;
  • allow the identification of the product; and
  • facilitate the adequate use of the experimental drug.

These mentions must be written in at least one of the following languages: French, German or Luxembourgish.

How is the promotion of off-label use regulated?

Physicians are asked to report to the director of the Ministry of Health if they prescribe a medicinal product for a use other than that originally intended (ie, an off-label use) and obtain their approval.

Relations with healthcare professionals

Gifts and incentives

What rules apply to the provision of gifts, discounts and other incentives to healthcare professionals?

It is forbidden to grant, offer or promise a bonus, pecuniary advantage or benefit in kind to healthcare professionals unless these benefits are of negligible value and do not relate to the practice of medicine or pharmacy.

Healthcare professionals may not request or accept any of the aforementioned provisions.

Free samples may be given to healthcare professionals only in exceptional circumstances and under specific conditions provided by law (see Articles 25 and 26 of the Grand Ducal Regulation of 15 December 1992 on the placing on the market of medicinal products (as amended) for further details).

Liability

Defect products

How can a liability claim for a defective medicinal product be brought?

The Ministry of Heath has a pharmacovigilance service that hears complaints for defective medicinal products. Such complaints can be filed by anybody.

The ministry suspends or withdraws the marketing authorisation of a medicinal products when it appears that:

  • the medicinal product is harmful under normal conditions of use;
  • the therapeutic effect is lacking; or
  • the medicinal product does not have the declared qualitative or quantitative composition;

The Ministry of Health appoints an expert commission which provides reasoned opinions on applications for marketing authorisation of medicinal products and, if appropriate, submits proposals for suspension or withdrawal of such marketing authorisation.

Which parties can be held liable for a defective medicinal product?

The manufacturing and marketing authorisation holder is liable for a defective medicinal product.

Remedies

What remedies are available to successful claimants?

These remedies are centralised at the EU level. No specific measure is available in Luxembourg.

Exclusion and limitation

On what grounds can liability be excluded?

This is centralised at the EU level. No specific measure is available in Luxembourg.

What preventive steps can be taken to limit liability?

To withdraw the medicinal product as soon as its defect is identified.

Compliance and enforcement

Enforcement

What measures are in place to enforce the laws governing medicinal products?

These measures are centralised at the EU level. No specific measure is available in Luxembourg.

Dishonest practices

What mechanisms are in place to combat bribery, fraud, collusion, counterfeiting and other dishonest practices in the pharmaceutical sector?

The European Commission will continue to support member states’ implementation of the EU Falsified Medicines Directive (2011/62/EU) – in particular, the medicine authentication system, which will apply to EU member states (including Luxembourg) in February 2019.