Ireland: PLC Life Sciences Multi-Jurisdictional Guide 2012

Last Updated: 22 May 2012
Article by Declan Hayes, Diana Diamond, Isabel Foley, Colin Kavanagh and Olivia Mullooly
Most Read Contributor in Ireland, August 2019

REGULATORY OVERVIEW

1. What is the regulatory framework for the authorisation, pricing and reimbursement of drugs, biologicals and devices (as they are termed in your jurisdiction)?

Legislation

Medicinal products. The regulatory framework for medicinal products in Ireland is based on Directive 2001/83/EC on the Community code relating to medicinal products for human use (as amended) (Code for Human Medicines Directive), which was implemented by the Irish Medicines Board Act 1995 (as amended) (IMB Act) and domestic regulations, most notably the Medicinal Products (Control of Placing on the Market) Regulations SI 540/2007 (as amended) (Marketing Regulations).

Medical devices. The regulatory framework for medical devices is contained in the following, as transposed into Irish law (Medical Devices Legislation):

  • Directive 93/42/EEC concerning medical devices (as amended).
  • Directive 90/385/EEC on active implantable medical devices (as amended).
  • Directive 98/79/EC on in vitro diagnostic medical devices (IVD Directive) (as amended).

The European Commission (Commission) proposes to replace the existing medical devices directives with one single regulation or directive consolidating and harmonising the law surrounding medical devices across the EU (see Question 35).

Regulatory authorities

The Irish Medicines Board (IMB) (see box, The regulatory authority) is responsible for regulating medicinal products and medical devices. The IMB is a statutory body created by the IMB Act.

Healthcare policy and expenditure is determined by the Department of Health and Children and administered through the Health Services Executive (HSE).

Biotechnology and combination products

All medicinal products, for human use derived from biotechnology and other high technology processes, must be approved by the European Medicines Agency (EMA).

Regulations on the contained use or deliberate release of genetically modified organisms (GMOs) in Ireland are implemented by the Environmental Protection Agency.

Combination products (medical devices incorporating a medicinal product) are regulated by the IMB under Medical Devices Legislation. They are subject to high levels of compliance assessment and classified as Class III (highest risk) devices.

PRICING AND STATE FUNDING

2. What is the structure of the national healthcare system, and how is it funded?

The Health Act 1970 (as amended) sets out the statutory basis for the structure of the national healthcare system. The public healthcare system is funded by the state through taxation and social security contributions. Private healthcare is funded by private insurance, social security schemes and private funds. The HSE was established by the Health (Amendment) Act 2004. The HSE integrates the delivery of health and personal social services. They are delivered through three service delivery units, namely:

  • Population Health, which promotes and protects public health.
  • Primary, Community and Continuing Care, which delivers health and personal social services in the community and other settings and funds payments to healthcare professionals.
  • National Hospitals Office, which provides acute hospital and ambulance services throughout the country.

There are three categories of hospitals in Ireland:

  • HSE hospitals.
  • Voluntary public hospitals owned by private bodies but which receive state funding.
  • Private hospitals which receive no state funding.

The Health Information and Quality Authority (HIQA) regulates and accredits public hospitals.

3. How are the prices of medicinal products regulated?

There is currently no specific legislation regulating the pricing of medicinal products. However, in September 2011 the Government approved the general scheme of the Health (Pricing and Supply of Medicines) Bill which provides for the introduction of reference pricing by the HSE and generic substitution for drugs prescribed under the CD Schemes (see Question 4). It is expected that the text of the implementing legislation will be published in 2012.

4. When is the cost of a medicinal product funded by the state or reimbursed to the patient? How is the pharmacist compensated for his dispensing services?

The HSE Primary Care Reimbursement Service (PCRS) operates ten Community Drug Schemes (CD Schemes) and provides reimbursement services to primary care contractors for the cost of providing health services and medicines to the public, along with fixed dispensing fees and mark-ups in certain circumstances.

A medicinal product is eligible for reimbursement if it:

  • Is approved by the HSE.
  • Is prescribed by a doctor.
  • Is dispensed by a doctor or pharmacist.
  • Holds a current Marketing Authorisation (MA).

Payments to pharmacists are regulated by HSE Community Pharmacy Contractor Agreements and the Health Professionals (Reduction of Payments to Community Pharmacy Contractors) Regulations 2011. A reduction in the wholesale mark-up rate from 10% to 8% on most drugs was implemented in 2011, according to the Financial Emergency Measures in Public Interest Act 2009. Payments to doctors are regulated by the HSE GP Contracts.

Reimbursement prices and procedures are agreed between the HSE and the Irish Pharmaceutical Healthcare Association (IPHA) and the Association of Pharmaceutical Manufacturers, respectively (Pricing Agreements). Price reductions were negotiated subsequently. New medicines, for which an MA has been granted, become reimbursable within 60 days of receipt of a reimbursement application by the HSE. High cost technologies may be referred by the HSE for pharmacoeconomic assessment before reimbursement, and the decision is notified within 90 days of receipt of the application.

Pricing Agreements use national price referencing and provide that the price to the wholesaler must not exceed the average wholesale prices in Belgium, Denmark, France, Germany, The Netherlands, Spain, Finland, Austria and the UK. If a product is not available in any of these reference countries, the wholesale price is agreed between the representatives of the manufacturer/importer and the HSE. Each month, manufacturers must rebate to the HSE 4% of the value of all medicines dispensed under the General Medical Services Scheme, which is one of the CD Schemes.

The current Pricing Agreements expire on 31 March 2012. However, their replacements have not yet been published. See Question 3.

MANUFACTURING

5. What is the authorisation process for manufacturing medicinal products?

Manufacturing is regulated by the Medicinal Products (Control of Manufacture) Regulations 2007 (as amended) (Manufacturing Regulations), which implement:

  • Title IV of Directive 2001/83/EC on the Community code relating to medicinal products for human use (Code for Human Medicines Directive).
  • Article 13 of Directive 2001/20/EC on the conduct of clinical trials (Clinical Trials Directive).
  • Chapter 3 of Directive 2005/28/EC on good clinical practice for medicinal products for human use (GCP Directive).

Application

A manufacturing authorisation is required for the manufacture, dividing up, packaging, labelling, presentation and importation of medicinal products from outside the European Economic Area (EEA). Applications are made to the IMB, and must include details of the:

  • Applicant.
  • Relevant medicinal products and pharmaceutical forms.
  • Proposed operations.
  • Premises, equipment and facilities.
  • Site master file.
  • "Qualified person", who ensures that each batch complies with law, the manufacturer's authorisation and the MA or equivalent. (He must be nominated by the applicant.)

Each applicant must give a written undertaking to comply with the conditions of the authorisation, if granted.

Conditions

Applicants must have suitable and sufficient premises, equipment and facilities, and appropriate and sufficient staff, including the qualified person (see above, Application). The IMB can grant, refuse or conditionally grant an authorisation.

An authorisation only applies to the following specified in the application and in relation to which it has been granted:

  • Medicinal products and pharmaceutical forms.
  • Manufacturing or importation operations.
  • Premises.

The manufacturer must not use the premises for any other purpose, and must comply with good manufacturing practice (GMP) and good distribution practice (GDP) (where applicable). The IMB must be informed of any change in qualified person or any particulars supplied in the application.

Restrictions on foreign applicants

There is no restriction on foreign applicants. However, the IMB only issues manufacturing authorisations for Irish manufacturing or importation sites.

Key stages and timing

Applications must be granted or refused by the IMB within 90 days. A request for further information by the IMB extends this period, and the expiry of 90 days does not mean that an implicit authorisation is granted. Applications to vary an authorisation due to a change to the medicinal products, pharmaceutical forms, premises or equipment or the manufacture, control or storage facilities must be granted or refused by the IMB within 30 days, unless an inspection is required. In this case, a decision is made within 90 days. All other decisions relating to variation applications are made within 60 days.

Fee

The application fee as of 1 January 2012 is EUR1,853. Annual renewal fees vary from EUR3,703 to EUR16,669, depending on the number of employees at the site. The variation fee is EUR274 for an administrative variation, and EUR768 for a technical variation. Current fees are available on the IMB website (www.imb.ie). (As at 1 November 2011, US$1 was about EUR0.7.)

Period of authorisation and renewals

Authorisations are valid indefinitely, unless otherwise specified by the IMB. Authorisations granted before 23 July 2007 continue in force until their expiry date. Renewal applications for such authorisations should be submitted three months before the expiry date. Renewals will not carry an expiry date.

6. What powers does the regulator have in relation to manufacturing authorisations?

Monitoring compliance

The IMB is responsible for monitoring compliance with manufacturing authorisations, GMP and GDP requirements. The IMB can:

  • Enter and inspect sites.
  • Inspect and copy records.
  • Conduct tests or examinations at the site.
  • Take samples for testing.

The IMB can investigate whether a manufacturer or importer has:

  • Obtained an authorisation and is complying with it.
  • At his disposal the qualified person approved by the IMB who meets the requirements and is fulfilling his obligations.

The IMB can vary an authorisation at any time. The IMB can suspend or revoke the authorisation in total or in relation to certain medicinal products, on notice in writing to the authorisation holder, on certain grounds.

Imposing penalties

Breach of the Manufacturing Regulations is an offence under the IMB Act, resulting in:

  • On summary conviction, a fine up to EUR2,000 or imprisonment for up to one year, or both.
  • On conviction on indictment for a first offence, a fine up to EUR120,000 or imprisonment for up to ten years, or both, and for a subsequent offence, a fine up to EUR300,000 or imprisonment for up to ten years, or both.

If an offence is committed by a corporate body, and is proved to have been committed with the consent, connivance or is attributable to the neglect of any person who is an officer or shareholder (if the shareholder manages the corporate body), this person may be personally liable for the offence.

CLINICAL TRIALS

7. Outline the regulation of clinical trials.

Legislation and regulatory authorities

Clinical trials are regulated by the European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004 to 2007, which implement:

  • Certain provisions of the Clinical Trials Directive and the GCP Directive.
  • In certain circumstances, the Control of Clinical Trial Acts 1987 to 1990.

The regulations apply to clinical trials conducted in human subjects and involving investigational medicinal products (IMP).

Authorisations

A clinical trial authorisation (CTA), issued by the IMB, must be obtained by a sponsor or person authorised to act on his behalf, who is established in the EU before commencing a clinical trial. Within 30 days of the application, the IMB gives written notice to the sponsor of its decision to either:

  • Refuse the authorisation, setting out grounds for the refusal.
  • Grant the authorisation.
  • Grant the authorisation, subject to conditions.

If no notice is given, a clinical trial can be treated as if it has been authorised. If the IMB refuses an authorisation or grants it subject to conditions, the sponsor can send an amended request to the IMB within 14 days. The IMB must then respond within 60 days with one of the following actions:

  • Setting out the grounds for refusing the amended application.
  • Granting the amended application.
  • Granting the amended application subject to conditions.

The procedure differs for clinical trials involving certain medicinal products, such as for gene therapy and somatic cell therapy including xenogenic cell therapy, or containing genetically modified organisms.

Consent

The sponsor must obtain the trial subject's informed consent, and inform each trial subject of the trial procedure and their right to withdraw at any time. Consent should include consents to data processing.

Trial pre-conditions

Before issuing a CTA, the IMB requires:

  • The sponsor, or the person authorised to act on his behalf in relation to the trial, to be established in the EU.
  • A favourable ethics committee opinion in relation to the trial protocol.

Insurance and indemnity cover for the conduct of the trial.

  • The sponsor to have registered with the EEA system for monitoring drug safety, EudraVigilance.

If a CTA application involves a trial site in a third country, the IMB can require an undertaking from the sponsor or the owner of the premises to allow the premises to be inspected by or on behalf of the IMB, to ensure that GCP is followed.

Procedural requirements

The trial must be conducted in accordance with GCP, and comply with:

  • The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals (ICH) Guidelines on GCP.
  • Commission Guideline ENTR/CT3 2006.
  • World Medical Association Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects 1964.

The sponsor must:

  • Notify the IMB within seven days of any breach of GCP.
  • Ensure that all correct safety reporting is conducted, and that urgent safety measures are taken when there is an immediate hazard to health or safety.
  • Maintain a trial master file and retain all essential documents relating to the clinical trial for at least five years after its completion.

MARKETING

Authorisation and abridged procedure

8. What is the authorisation process for marketing medicinal products?

Application

The placing of medicinal products on the market is regulated by the Marketing Regulations, which implement certain provisions of the Code for Human Medicines Directive.

Subject to certain exceptions (including clinical trial supplies), a medicinal product cannot be placed on the market in Ireland unless an MA has been granted for that product by the IMB or, where appropriate, the EMA.

An MA can be obtained by applying to the IMB through the following procedures:

  • National procedure. When granted, the MA entitles the marketing authorisation holder (MAH) to only place the medicinal product on the Irish market.
  • Mutual recognition procedure. If the medicinal product has received an MA in another EEA member state (Reference Member State), the MAH can apply to one or more other member states (Concerned Member State) to recognise that authorisation. If a product has received an MA in another member state, the MAH can apply to the IMB to mutually recognise that authorisation in Ireland.
  • Decentralised procedure. This can be used if the product has not yet received an MA in a member state, and the applicant wishes to apply for simultaneous authorisation in two or more member states. The applicant nominates one of the states as the Reference Member State, whose competent authority examines the application in full and prepares a report for the competent authorities of the Concerned Member State(s). The IMB is the competent authority for these applications in Ireland.
  • Centralised procedure. A Community MA, which is valid throughout the EEA, can be obtained by applying to the EMA, through the centralised procedure governed by Regulation (EC) 726/2004 on the authorisation and supervision of medicinal products and establishing a European Medicines Agency (as amended) (EMEA Regulation). The Centralised Procedure is compulsory for certain medicines.

Authorisation conditions

The applicant must be established in an EEA state. Applications (whether to the IMB or EMA) must be accompanied by the appropriate fee and certain documents and particulars, including:

  • A summary of the product characteristics (SmPC).
  • A mock up of the packaging and package leaflet.
  • The requisite safety, quality and efficacy data (including clinical trial results, and a description of the proposed pharmacovigilance system).

Applications under the mutual recognition or decentralised procedure must:

  • Include a list of all the Concerned Member States.
  • Confirm that the dossier, the SmPC, package leaflet and labelling are identical in all of the member states involved.

Other conditions

To maintain authorisation following market entry, the MAH must comply with certain pharmacovigilance requirements (see below, Post-marketing commitments and pharmacovigilance obligations).

Key stages and timing

The key stages and timing are determined by the procedure used.

Under the national procedure, the Marketing Regulations do not specify any timescale within which the IMB must consider the application. If the application is refused, the applicant has the right to make representations to the IMB.

Fee

The applicable fees are available on the IMB website. As of 1 January 2012, the following fees apply for new applications (with complex dossiers and new active substances not previously licensed in Ireland):

  • National application: EUR15,211.
  • Mutual recognition incoming: EUR10,647.
  • Decentralised incoming: EUR15,211.
  • Decentralised outgoing: EUR40,000.

The fees for the centralised procedure are available on the EMA website (www.ema.europa.eu).

Period of authorisation and renewals

Unless a shorter time period is specified, an MA is valid for five years. If the product is not placed on the market within three years of authorisation or is not on the market for three consecutive years, the authorisation ceases to be valid. Renewal applications must be made at least six months before expiry of the current MA. If successfully renewed, the MA remains valid for an indefinite period (unless further renewals are required for pharmacovigilance reasons).

Post-marketing commitments and pharmacovigilance obligations

The Marketing Regulations require that a MAH must comply with certain pharmacovigilance requirements to maintain its MA. The pharmacovigilance framework is based on:

  • The Code for Human Medicines Directive (for nationally authorised products, and products authorised through the mutual recognition and decentralisation procedures).
  • EMEA Regulation (for centrally authorised products).

The MAH must:

  • Nominate a qualified person responsible for pharmacovigilance.
  • Keep records of all suspected adverse reactions.
  • Report serious adverse reactions to the IMB/EMA.
  • Submit Periodic Safety Update Reports (PSURs) to the IMB/EMA at specified intervals.

An amended pharmacovigilance system (set out in Regulation (EU) 1235/2010 concerning pharmacovigilance of medicinal products for human use and Directive 2010/84/EU amending, as regards pharmacovigilance (Code for Human Medicines Directive)) is intended to be implemented in Ireland by July 2012.

Other post-marketing commitments required by the Marketing Regulations include:

  • Informing the IMB of:
  • the date that the medicinal product is placed on/ removed from the market;
  • any MA restrictions imposed by other jurisdictions on the product; and
  • defects identified in the product.
  • Ensuring that sufficient supplies of the product are provided to pharmacies on an ongoing basis.

9. Which medicinal products can benefit from the abridged procedure for marketing authorisation and what conditions and procedure apply? What information can the applicant rely on?

An applicant is not required to provide the results of pre-clinical and clinical trials if he can demonstrate that the product is either a generic medicinal product, or a similar biological product to a product which has been authorised in the EU for at least eight years (or six years, if the application for the reference product was submitted before 30 October 2005).

The application for authorisation of the generic or similar biological product can be made to the IMB eight years after authorisation of the reference product, when the period of data exclusivity for the reference product expires. If the application for the reference product was made before 30 October 2005, this period is reduced to six years.

However, the generic or similar biological product, once authorised, cannot be placed on the market for ten or 11 years from authorisation of the reference product (depending on the marketing exclusivity period available for the reference medicinal product) (Code for Human Medicines Directive) (see Question 23).

An abridged procedure is also available for:

  • Applications relying on well-established (ten years) medicinal use of the active substance involved, where the applicant can replace the results of pre-clinical and clinical trials with the appropriate scientific literature.
  • Applications relating to new fixed combination products, where the results of new pre-clinical or clinical trials are provided, but scientific references relating to each of the individual substances are not required.
  • Applications where the product possesses the same qualitative and quantitative composition as an authorised medicinal product, and the original MAH gives his consent to the use of his dossier for examining the application in question.

10. Are foreign marketing authorisations recognised in your jurisdiction?

An MA issued by, or an application for an MA submitted to, the competent authority of another EEA state, can be recognised in Ireland under the mutual recognition or decentralised procedure (see Question 8). MAs issued by countries outside the EEA are not recognised in Ireland.

11. What powers does the regulator have in relation to marketing authorisations?

Monitoring compliance

The IMB is responsible for monitoring compliance with MAs. The IMB has wide-ranging powers relating to:

  • Entry and inspection of sites.
  • Inspection and copying of records.
  • Conducting tests or examinations at the site.

Taking samples for subsequent testing.

The IMB also relies on manufacturers, healthcare professionals and the public to report adverse events and misleading information regarding medicinal products.

Imposing penalties

The IMB (or, where appropriate, the EMA) can issue an urgent safety restriction relating to a product on the market or it can revoke, suspend or vary an MA, for a specified period or until further notice. Breach of the Marketing Regulations is an offence under the IMB Act. Liability is the same as for breach of the Manufacturing Regulations (see Question 6).

Parallel imports

12. Are parallel imports of medicinal products into your jurisdiction allowed?

Parallel imports of medicinal products from other EU member states and EEA countries into Ireland are allowed under the following two schemes. Products centrally authorised by the EMA are not covered by these schemes and require separate notification to the EMA before parallel importation. Parallel importers, who distribute products in Ireland and do not hold a manufacturer's authorisation, must hold a wholesaler's authorisation.

Dual pack import registration (DPR)

If the parallel-imported product (parallel product) is identical to the Irish market reference product (original product), the importer can use the DPR procedure. A DPR is granted by the IMB if all the following criteria are fulfilled:

  • The original product has a valid and current MA.
  • The parallel product is imported from another EEA country and it has a valid and current MA in that country.
  • The parallel product is identical to the original product, including the packaging, label, package leaflet and SmPC.
  • The importer has given the original product MAH one month's notice of its intention to parallel import before submitting its application for a DPR.

A DPR is valid indefinitely, provided the parallel importer submits an annual declaration of compliance with the above criteria. Parallel importers who engage in labelling and repackaging must hold a manufacturer's authorisation (see Question 5).

Parallel product authorisation (PPA)

A PPA is required if the parallel product differs from the original product. A PPA is granted by the IMB if all the following criteria are met:

  • The original product has a valid and current MA or if not, the MA has been withdrawn for commercial reasons only.
  • The parallel product is imported from another EEA country (subject to certain derogations) and it has a valid and current MA in that country.
  • The parallel product has the same active substances and pharmaceutical form as the original product and is therapeutically equivalent to it.

The PPA can be granted indefinitely or may be limited to a maximum of five years for pharmacovigilance reasons. If renewed after this five-year period, it remains valid indefinitely. A PPA can be granted or remain in force if the original product MA is withdrawn for commercial reasons or is replaced by a new version. The PPA is invalidated if the parallel product ceases to have a valid MA in the country from which it is imported. The distributor must also provide the MAH in the Irish market, with one month's notice of its intent concerning parallel importation. Further notice must be given if the product is to be re-packaged.

Intellectual property rights (IPRs)

Within the EEA, if the IPR holder places or consents to the placement of the product on the market in one EEA state, it cannot generally rely on its rights to prevent that product being imported to or marketed in another EEA state.

However, patent rights can be invoked to prevent the parallel import of pharmaceutical products manufactured or marketed in states which have recently joined the EU (accession state), provided it was not possible to patent the product in the accession state at the time it was put on the market there. The parallel importer must inform the patent holder of its intention to import from the accession state. The patent holder then has one month to take action.

IPRs can be used to oppose parallel imports from outside the EEA.

Restrictions

13. What are the restrictions on marketing practices such as gifts, sponsoring, consultancy agreements or incentive schemes for healthcare establishments or individual medical practitioners?

The promotion of medicinal products to healthcare establishments and professionals is governed by the Advertising Regulations and the IPHA Industry Code (see Question 15).

The giving of any gift, pecuniary advantage or benefit-in-kind to a person qualified to prescribe medicinal products is prohibited, unless it is inexpensive and relevant to the practice of medicine or pharmacy. This prohibition does not apply where hospitality is provided at sales promotion or other events for purely professional and scientific purposes, provided it is:

  • Reasonable in level.
  • Limited to the scientific objective of the event.
  • Not provided to any persons other than healthcare professionals.

Free samples cannot be supplied to any person other than a person qualified to prescribe such product and where a number of conditions are satisfied. No more than four samples of any product, in the smallest presentation of the product available, can be supplied to one recipient in a year, and the supply must be in response to a signed and dated written request from the healthcare professional.

Companies are not prevented from providing educational, research or employment grants, donation or sponsorship of equipment, provided certain conditions are met. Any grants must be paid directly to an institution rather than an individual, healthcare professional and this support must not be linked in any way to product promotion.

The Ethics in Public Office Acts 1995 (as amended) and the Civil Service Code of Standards are also relevant. Holders of certain public positions (including senior personnel within the HSE, the IMB, the Department of Health and Children and in voluntary hospitals) must disclose certain interests to the Standards in Public Office Commission. These include gifts and/or the provision of travel facilities, living accommodation, meals or entertainment valued at more than EUR650 in aggregate in any given year. While responsibility for compliance rests with the recipient of the gift, the provider of the gift can be requested to assist the Standards in Public Office Commission in its investigations, and failure to do so can be a criminal offence.

14. What are the restrictions on marketing medicinal products on the internet, by e-mail and by mail order?

Subject to certain exceptions, the supply of prescription-only medicinal products through the internet, by e-mail, mail order or any other distance means of communication is not permitted.

Non-prescription medicines can be advertised to the public through the internet or by post, telephone, e-mail or other electronic communications, subject to certain restrictions. The advertisement must not give the impression that a medical consultation or surgical operation is unnecessary, particularly by offering a diagnosis or by suggesting treatment remotely.

To read the remainder of this article please click here.

This article contains a general summary of developments and is not a complete or definitive statement of the law. Specific legal advice should be obtained where appropriate.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Authors
Similar Articles
Relevancy Powered by MondaqAI
 
In association with
Related Topics
 
Similar Articles
Relevancy Powered by MondaqAI
Related Articles
 
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.

Disclaimer

The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.

General

Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions