Marketing, Manufacturing, Packaging & Labeling, Advertising
All about marketing, manufacturing, packaging & labeling, advertising in Ireland. Prepared in association with Mason Hayes & Curran, a leading law firm in Ireland, this is an extract from The Pharma Legal Handbook: Ireland, available to purchase here for USD 99.
1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products?
See Question 1 of Regulatory, Pricing and Reimbursement Overview.
2. What is the authorization process for the marketing of generic versions of these products?
See Question 6 of Regulatory, Pricing and Reimbursement Overview.
3. What are the typical fees for marketing approval?
See Question 4 of Regulatory, Pricing and Reimbursement Overview.
4. What is the period of authorization and the renewal process?
See Question 5 of Regulatory, Pricing and Reimbursement Overview.
5. What are the requirements, if any, for post-approval pharmacovigilance?
Directive 2001/83/EC and and Regulation (EC) No 726/2004 (as amended) outline the legal basis for phamacovigilance for medicines intended for human use. The legislation requires MA holders (MAH) to be proactive and responsible for the on-going pharmacovigilance of their products and have in place a pharmacovigilance system. They are also required to have a qualified person within the EEA responsible for their pharmacovigilance and all relevant details must be stored on a pharmacovigilance master file.
Further to the this, MA applications must have a risk management plan (RMP) outlining the risk management system put in place which must identify the safety profile of the product, as well as measures for the prevention or minimisation of risks associated with product and identify the post-authorisation obligations that have been imposed as a condition of the MA.
Device manufacturers must have systems for review of post – market experience and are obliged to report incidents to competent authorities and take necessary corrective measures. They must keep a copy of the technical documentation underpinning their CE marking and it must be available for inspection by the HPRA on their request.
6. Are foreign marketing authorizations recognized?
No, medicinal products can only be placed on the market in the EEA after MAs are issued via either the CAP or via the other three MA methods outlined in Chapter 1. EU law requires that MAH, qualified persons for pharmacovigilance and sponsors for orphan medical products must be established in the EU.
7. Are parallel imports of medicines or devices allowed?
Yes, parallel imports are allowed in Ireland following authorisation from the HPRA. A product which has parallel product authorisation is identifiable from the letters ‘PPA’ in front of the authorisation number. Parallel distribution of products authorised by the European Commission (“centrally authorised products”) should be notified to the EMA as opposed to the HPRA.
8. What are the restrictions on marketing practices such as gifts, sponsorships, consultancy agreements, travel and entertainment, or other incentives for healthcare organizations and individual medical practitioners?
Article 94 of Directive 2001/83EC provides rules restricting the supply of medicine samples, promotional aids, gifts, hospitality, and other incentives to healthcare organisations and medical practitioners. Where products are being promoted to medical practitioners, no pecuniary advantages or gifts can be “supplied, offered or promised unless they are inexpensive and relevant to the practice of medicine or pharmacy”. Hospitality for sales promotion events must be strictly limited to their main purpose and cannot be extended to persons other than healthcare professionals.
The Pharmaceutical Code outlines many similar provisions with further details in respect of consultancy agreements, donations and grants as well as the provision of hospitality between healthcare organisations and professionals.
Healthcare professionals must have regard to the ethical requirements of their own professional bodies when interacting with the medical device or pharmaceutical industries.
9. How is the manufacturing of medicines and devices regulated and by which agencies?
The manufacturing of medicines and devices is regulated by the HPRA. The legislation applying to the manufacture of medicinal products is Statutory Instrument No. 539/2007 Medicinal Products (Control of Manufacture) Regulations 2007 (as amended). The HPRA issues manufacturing import authorisations (MIAs) to applicants who wish to manufacture or import medicinal products in Ireland. The HPRA will assess the documentation provided with the application and as part of the process may decide to inspect the site. Foreign applicants can apply for MIAs but, the HPRA can only issue MIAs for Irish manufacturing or importation sites.
As part of EU manufacturing controls, manufacturers are obliged (amongst other requirements) to abide by the principles of Good Manufacturing Practice and have a qualified person overseeing the process at all times, the HPRA undertakes the role of ensuring compliance with these obligations. As part of its role, it can conduct inspections, conduct tests and examinations and investigate compliance with authorisations.
As per Question 2 of Regulatory, Pricing and Reimbursement Overview, the HPRA has designated the NSAI as the NB in Ireland and it carries out conformity assessment procedures to ensure compliance with EU Medical Devices legislation. Device manufacturers must keep a copy of the technical documentation relating to its CE mark and have it available for inspection on request. Certificates of conformity are available for fixed durations, and there will have to be a new audit by the NB prior to renewal of a certificate.
10. Are local manufacturing requirements compatible with Good Manufacturing Practices (GMPs) as defined by the US Food & Drug Administration (US FDA) and/or the European Medicines Agency (EMA)?
Manufacturing requirements in Ireland must be in compliance with the EU Guide to Good Manufacturing Practice (GMP). The principles are set out in Directive 2003/94/EC and the Commission’s Guidelines in Volume 4 of the Rules governing medicinal products in the EU.
Manufacturers are required to have at least one person permanently available to oversee and ensure that each batch sold on the market is in compliance with GMP and the requisite specifications in the marketing authorisation dossier. If the products are imported from outside the EEA, the qualified person must verify that each batch has undergone quality control testing in the MS before its release onto the market.
In terms of medical devices there are no EU rules requiring approval of manufacturing facilities, but a notified body could carry out a conformity assessment of the manufacturer’s quality assessment. The manufacturer must demonstrate compliance with the applicable harmonised standards for quality, with any changes provided to the notified body for their approval.
11. What is the inspection regime for manufacturing facilities?
Inspections of medicinal product manufacturing facilities are carried out by the HPRA to ensure compliance with EU pharmacovigilance obligations. Inspections by the HPRA’s GMP inspectors take place every 2 – 3 years; however the frequency may differ depending on the activities of the site and the findings of previous inspections. The objectives of pharmacovigilance inspections are as follows:
- to determine that the marketing authorisation holder has personnel, systems and facilities in place to meet their pharmacovigilance obligations;
- to identify, record and address non-compliance which may pose a risk to public health; and
- to use the inspection results as a basis for enforcement action, where considered necessary.
There are different types of inspections such as those relating to pharmacovigilance systems inspections, pre-authorisation inspections, for – cause inspections (where a trigger is recognised and an inspection is considered an appropriate way to tackle the issues), routine inspections and product – related pharmacovigilance inspections (focused on products rather than systems).
MAH is usually notified four to six weeks prior to the inspection, however the HPRA has the right to either provide a shorter notice period or conduct an unannounced inspection. Inspections commence with an opening meeting conducted by the inspectors who may undertake a review of the facilities as part of the process. At the end of the inspection a final meeting is held where preliminary verbal feedback is provided. The findings are graded from minor deficiencies, major deficiencies to critical deficiencies and these are issued in a report to the company within 15 calendar days from the last day of inspection. Inspectees are required to provide a written response to the report within 35 days of the report being provided; this response should detail any measures they will be taking to address deficiencies.
The HPRA is the competent authority for medical devices in Ireland and as such can conduct post – market surveillance of products manufactured by Irish based manufacturers, as well as those placed on the Irish market. This surveillance is part of the review of the manufacturer’s compliance to the EU Medical Devices Directives (soon to be fully replaced by the Medical Devices Regulation) and related Irish legislation.
Post – market surveillance is carried out either by proactive surveillance (e.g. targeted audits for a specific category) or ‘for – cause’ audits as a result of market issue, and require follow-up in the interest of public health. Audits by the HPRA do not necessarily mean that there has been a breach of the legislation, if it is part of a proactive programme of surveillance.
The HPRA will contact the manufacturer to arrange the date, time and duration of the audit, and the manufacturer is requested to supply information in advance, such as a brief company profile, the details of the NB and relevant procedures. Similar to medicinal products, there are opening and closing meetings and at the closing meetings, any non-compliance with the relevant legislation is raised and a timeframe for corrective action agreed with the medical device manufacturer. Non-compliance is categorised as either major non-compliance or minor non-compliance.
Once there are satisfactory responses received by the HPRA in relation any non-compliance, the HPRA will issue a letter to the medical device manufacturer to that effect. However, in the event that breaches of regulations have taken place, the HPRA can choose to undertake use of its enforcement powers.
12. Are manufacturing facilities open for inspection by foreign inspectors or third-party inspectors as authorized by the FDA/EMA?
Yes, manufacturing facilities in Ireland can be inspected by third party inspectors on request of the EMA. Conversely, the HPRA can carry out inspections of third country manufacturers where the inspections have been delegated by a supervisory authority in another MS.
13. What are the requirements for storage, packaging, and handling of medicines and devices and their constituent components?
Storage & Handling
The Irish legislative basis for exercising control over the chain of distribution of medicinal products is Directive 2001/83/EC transposed into Irish law by Medicinal Products (Control of Wholesale Distribution) Regulations 2007 (as amended by Statutory Instrument No. 538 of 2007). The EU has also issued ‘Guidelines on Good Distribution Practice of Medicinal Products for Human Use’ which are also to be complied with. Medicinal products should be stored and transported in conditions which ensure their quality is maintained and the products should be checked against their label requirements.
Stability testing is necessary to ensure that a product is of acceptable quality throughout its storage period and the results of stability test dictate the special storage conditions for active substances as well as for medicinal products. It is necessary to monitor compliance of the product with quality specification throughout its shelf life. Products must be stored according to conditions described on the label (e.g. “Do not refrigerate/Do not freeze”). For many medicinal products, storage and transportation temperatures are a huge factor in maintaining their quality throughout the distribution process, and one of the key requirements of a MA is that the storage conditions are met. The distribution chain may involve a number of storage and transit locations, including airports, docks, and a variety of methods of transport, including aircraft. It is therefore incumbent on manufacturers and others involved throughout the distribution network that temperatures are monitored and documented using calibrated measuring devices.
The legislation has detailed and complex requirements surrounding the distribution and transportation of ‘cold-chain’ medicinal products whilst under their care as well as requirements for controlled temperature storage. For ‘cold-chain’ products, those in the distribution process must consider issues such as:
- The nature of the products and the volumes/quantities to be stored.
- The power back-up facilities for the unit itself and for the temperature monitoring and recording system.
- The procedures for checking functionality and compliance of the unit with its temperature specifications (i.e. daily checks).
There are also various specifications relating to large and small volume operations as to their external conditions and location of thermometer(s) and so forth.
‘Controlled temperature storage’ relates to products which do not require cold storage or freezing, and unless specified in the product literature or labels, medicinal products can be sorted under conditions of room temperature without compromising stability or the recommended shelf life. The legislation requires temperature mapping in storage spaces (including warehouses) to ensure that all locations are likely to remain within seasonal temperature limits. If there is significant modification to the premises, there should be a repeat temperature mapping process. There should also be continuous temperature monitoring as well as daily record checking and independent reviews of these records by a Responsible Person (RP).
Where certain products require storage, handling and transportation in a frozen sate (e.g. blood products), the temperature mapping exercise needs to be employed as part of a risk assessment to identify monitoring locations as well as the suitability of the unit. Temperature records must be checked daily and independently reviewed by a RP, with any deviations outside the limits documented.
Temperature monitoring devices must be calibrated annually to against a certified, traceable reference standard. Products should not be stored in areas shown by temperature mapping to present a risk and there must be sufficient space between the products and the internal surfaces to permit adequate air circulation.
EU Regulation 2016/161 supplements Directive 2001/83/EC and lays down detailed rules on the ‘safety features appearing on the packaging of medicinal products for human use’. Prescription medicines and some non-prescription medicines must have a unique identifier carried by a 2-d barcode and an anti-tampering device (ATD). Where medicinal products have no outer packaging, the ATD is placed on the immediate packaging and there are specific rules about how it affects the contained and its closure system(s).
Article 14(3) of the new EU Medical Devices Regulations (2017/745) lays out the conditions for the storage requirements of medical devices. It states distributors must ensure that while devices are under their responsibility, they must adhere to the storage or transport conditions set by the manufacturer. The specifications for storage conditions are usually on the outside of containers (e.g. “store at -20°Celsius”), devices must be stored in accordance with labelled conditions. If there are no specifications regarding storage, then there are no temperature restrictions at which the device must be stored. There must be continuous temperature monitoring and this must be documented, these records should be reviewed and approved regularly to ensure compliance with the specified conditions.
Under the new Medical Devices Regulations (2017/745) the following requirements must be adhered to for the packaging of medical devices to maintain the sterile condition of the device:
- an indication permitting the sterile packaging to be recognised as such
- a declaration that the device is in a sterile condition
- the method of sterilisation
- the name and address of the manufacturer
- a description of the device
- if the device is intended for clinical investigations, the words ‘exclusively for clinical investigations’
- if the device is custom-made, the words ‘custom-made device’
- the month and year of manufacture
- an unambiguous indication of the time limit for using or implanting the device safely expressed at least in terms of year and month
- an instruction to check the instructions for use for what to do if the sterile packaging is damaged or unintentionally opened before use
As regards the handling and transportation of medical devices, they must be transported appropriately and in accordance with labelled storage conditions (including sterile conditions if applicable) and written procedures.
If there is a contract service provider, the distributor must make itself aware of the operating procedures of that party and should conduct an examination of the transportation methods and routes.
Furthermore, the distributor should be fully aware of, and agree to, any operations to be sub-contracted. The contracted arrangements for transportation should be documented in a service level agreement, and should include details of sub-contracting. Finally, the distributor must ensure that medical devices are not subjected to prolonged periods of storage during transportation.
14. What information must be included in medicine and device labeling?
The HPRA has issued guidance on labels and leaflets for human medicines, and the requirements for products applications submitted after the 23 July 2007 are outlined in Directive 2001/83/EC (as amended by Directive 2004/27 EC) and transposed into Irish law by the Medicinal Products Regulations 2007. The regulations applicable to products authorised prior to this date are the Medicinal Preparations (Labelling and Package Leaflet) Regulations 1993 (Statutory Instrument No. 71 of 1993). The EU has published a series of guidelines which are also applicable to labels and package leaflets and some of these are:
- Annex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’
• Guideline on the Readability of the Labelling and Package Leaflet of Medicinal Products for Human Use
• Note for guidance on Declaration of Storage Conditions A: in the Product Information of Medicinal Products B: for Active Substances
Articles 54 – 69 of Directive 2001/83/EC provide detailed requirements for labels and leaflets and they should be prepared in line with the supplemental EU guidelines. The requirements outlined in the Directive are in regards to:
- The presentation of the product name on the label, which must contain all elements required in Article 54. For prescription products the invented name, strength and pharmaceutical form as well as the actives should be in that order and should include the strength of all active substances in the product where there are multiple active substances. For over-the-counter (OTC) and general sale product there is a specific format for actives. Images should be avoided on labelling as this could interfere with readability of the name, and it is not advised to use a mixture of capital and small letters
- Article 54 also requires that there is adequate space for labelling of the prescribed dose which should be large enough for a regular pharmacy dispensing label to be applied without obscuring the text
- There are specific guidelines for the labelling of individual perforated blisters
- The Directive allows the use of multilingual text with the proviso that the same text appears in all the languages used. The HPRA actively encourages the use of multilingual labelling ad packaging leaflets and there are strict criteria which multilingual packaging must fulfil
- Labels of vaccine or plasma derived medicinal products must contain a double peel-off label to allow duplicate records to be retained of critical information. One label is to be placed on the patient’s record charts and other retained for administrative purposes to facilitate traceability of doses and the recording of batch numbers and expiry dates
- Label and leaflet combinations present challenges in ensuring that information is presented in a legible manner. There are specific type size and fonts required under the legislation
- The declaration of strength for liquid parenterals (quantity per millilitre and total amount per total volume) should be listed on outer and inner labels
- The name on top of the leaflet packaging must correspond to section 1 of the SmPC (Summary of Product Characteristics)
- Technical package leaflets are not required for all products but are recommended for example, where the information is too extensive to include in the ‘take/use’ section (Section 3) of the package leaflet
- Article 56a of Title V Directive 2001.83/EC was introduced to ensure improved access to information on medicines for people with visual impairment and thus there are extensive requirements relating to Braille on labelling and packaging. The HPRA has issued specific guidance to ensure compliance with the requirements
- Article 56a also obliges MA holders to provide patient information leaflets in formats suitable for the blind and those who are partially sighted in order to ensure access to information on medicines
Directive 93/42/EEC contains the basic legal framework for the regulation of medical devices in the EU, however this has been repealed by the new Medical Devices Regulation 2017/745 (MDR). Under Directive 93/42/EEC, all devices had to meet “essential requirements” as detailed in Annex I, and these related mainly to the design and construction of devices to include labelling. Once companies adhered to the requirements within Annex I, the device could be CE marked, certifying compliance and was thus entitled to be sold throughout the EU.
As a general principle, the legislation requires medical devices to be accompanied with as much information as is necessary for the safe use of the device, taking into account training and knowledge of potential consumers. Basic instructions must appear on the label, with more detailed instruction enclosed. All devices are to be labelled with the name and address of the manufacturer and for imported devices, the name and address of either the importer or their authorised representative in the EU. Labels are also to contain operating instructions, warnings and precautions, and if the purpose of the device is not immediately obvious, then it must be clearly stated on the label and instructions.
The instructions must have particulars in relation to details required on the labels, potential side effects from use of the devices and any specific precautions. As regards the language for labels, MS were required to specify in their implementing legislation the language to be used on any packaging and any labels.
The new MDR (under Chapter III, Article 23) contains the same requirements as above, but builds upon and elaborates the labelling obligations in the previous Directive and as such, will require manufacturers to alter their labels as previously printed. The motivation behind the legislation is have data-led labelling system. These new requirements include, but are not limited to, requirements for single-use devices, hazard warnings, electronic labelling, clinical investigations, electronic instructions for use and the introduction of mandatory symbols. There is also a requirement for a new symbol demonstrating that the package contains a medical device, and this means all companies will be required to amend their labels to include the new symbol. The new legislation has also introduced a unique device identifier (UDI) requirement for all devices manufactured in the EU.
15. What additional information may be included in labeling and packaging?
Article 62 in Directive 2001/83/EC states that outer packaging, leaflets and outer labelling can also include symbols or pictures to clarify information mentioned in Article 54 or 59(1) or any other information in line with the SmPC but cannot contain any misleading or promotional material and cannot interfere with legibility. Outer packaging and labelling can also include information for which the product has been prescribed (as long as it is in line with Article 62 of Directive 2001/83/EC).
Telephone numbers, fax numbers or email addresses are permitted as long as they are accessible to Irish patients, and can be included in the printed ver- sion of the SmPC. Contact details for independent patient organisations can be included as long as they are accessible to Irish patients and are not websites.
Under Article 13(3) of the new MDR, in order that their location be established, importers should indicate on the device or in an accompanying document their name, registered trade name or trade mark, their registered place of business and the address at which they can be contacted.
16. What items may not be included in labeling and packaging?
The following are not allowed on labelling and packaging of medicinal products:
- Website addresses, as references to websites, coupons, product-specific phone lines, mail clubs etc are considered to be promotional in nature and thus are not permitted. References to websites pertaining to patient organisations or for medical conditions are also not permitted
- Accreditation logos or statements e.g. ‘organic, ‘Kosher’, ‘Halal’ or ‘Guaranteed Irish’ are not permitted. The sole exception being the recycling symbol which can be used on the label or leaflet
- Forms either in the package leaflet or coupons requesting patients to send their details for further information are considered promotional and not acceptable
- The use of ‘New’ or ‘New product’ may not be used for promotional purposes on product labelling, but can be used to alert pharmacists and patients to a change in an existing product
17. What are the restrictions and requirements for the marketing and advertising of medicines and devices?
The advertising of human medicinal products is governed by Statutory Instrument No. 541 of 2007 Medicinal Products (Control of Advertising) Regulations 2007 (the Advertising Regulations). This legislation transposed Title VIII of European Directive 2001/83/EC (as amended) “The Advertising of Medicinal Products for Human Use”. The European Communities (Misleading and Comparative Marketing Communications) Regulations 2007 (the Misleading Advertising Regulations) also apply.
Medical devices do not fall under this legislation; any medical device being advertised in Ireland must bear a CE mark and comply with the Advertising Standards Authority for Ireland’s (ASAI) Code of Standards for Advertising, Promotional and Direct Marketing and the MDR. Prescription – only medicines, controlled drugs and certain sizes of non – prescription medicinal products cannot be advertised to the general public. The Advertising Regulations outline in Part 3 the provisions for advertising to the public, and in Part 4 the provisions for advertising to persons qualified to prescribe or supply medicinal products.
The HPRA monitors the advertising of companies who hold MAs for medical products, and thus, unlicensed medical products do not hold MAs and therefore cannot be legally advertised. Advertisements to the public must be accurate, and present the medicinal product objectively and encourage rational use of the product, as well as ensuring consistency with the MA and SmPC.
As per Section 11, Part 3 of the Advertising Regulations, an advertisement cannot be issued if it:
- gives the impression that a medical consultation or surgical operation is unnecessary, in particular by offering a diagnosis or by suggesting treatment by mail
- suggests that the effects of taking the medicinal product are guaranteed, are unaccompanied by adverse reactions or are better than, or equivalent to, those of another treatment or medicinal product
- suggests that the health of the subject can be enhanced by taking the medicinal product
- suggests that the health of the subject could be affected by not taking the medicinal product
- is directed exclusively or principally at children
- refers to a recommendation by scientists, health professionals or persons who are neither of the foregoing but who, because of their celebrity status, could encourage the consumption of medicinal products
- suggests that the medicinal product is a foodstuff, cosmetic or other consumer product
- suggests that the safety or efficacy of the medicinal product is due to the fact that it is natural
- might, by a description or detailed representation of a case history, lead to erroneous self-diagnosis
- refers, in improper, alarming or misleading terms, to claims of recovery
- uses, in improper, alarming or misleading terms, pictorial representations of changes in the human body caused by disease or injury, or of the action of a medicinal product on the human body or parts thereof
Advertising of medicinal products is not only regulated by the ASAI and the Advertising Regulations. The IPHA Code of Standards for Advertising Practice for the Consumer Healthcare Industry (Revision 5.2) 2017 contains further restrictions and requirements in respect of the content of advertisements:
- All advertisements must be accurate and truthful
- All advertisements must be easily intelligible to the consumer
- All advertisements must comply with Medicinal Products (Control of Advertising) Regulations 2007 e.g. in relation to the format of advertisements and reminder advertisements
- Advertisements must not bring the industry into disrepute, undermine confidence in advertising or prejudice public confidence in medicinal products
- Advertisements cannot induce or tend to induce fear or encourage unnecessary use of product
- Advertisements cannot contain exaggerated claims or use words such as ‘magic’ or ‘mystical’ in connection with claims made for the product or treatment
- Testimonials cannot be used except where they are the genuine views of the user and cannot be used in an advertisement for more than three years after the date on which they were produced by users
On the whole, provisions regarding the restrictions and requirements for advertising and marketing of medicinal products in the ASAI Code, the IPHA Code of Standards for Advertising Practice and the Advertising Regulations reflect each other in a bid to ensure consistency and clarity surrounding the promotion of medicinal products to the general public.
18. Where can medicines and devices be sold or delivered? Can medicines and devices be sold or delivered via post?
Medicines and devices can be sold in pharmacies, shops and in the cases of non – prescription products and devices, in supermarkets. They can also be sold and delivered by post however, restrictions do apply. The legal framework for purchasing medicines online in Ireland is set out in Directive 2001/83/ EC as amended by Directive 2011/62/EC. Non – prescription medicines can be purchased from online retailers who display the EU ‘Common Logo’. A link must be provided, through the logo to the Internet Supply List on the Pharmaceutical Society of Ireland’s (PSI) website. This is to verify that the consumer is purchasing from a legitimate supplier and combat the risks of purchasing falsified medicines which may not work or be harmful to the user.
19. What are the restrictions and requirements for electronic marketing and advertising via email, by internet, social media, and other channels?
The restrictions and requirements relating to advertising of medicinal products also apply to advertising via email, the Internet, social media and other channels. That is to say, only non – prescription products can be advertised to the public. Annex IV of the IPHA Pharmaceutical Code, ‘Guideline on Digital Communication in the Pharmaceutical Sector’ aims to facilitate compliance and provide advice for the benefit of patients and healthcare professionals. The section states that nowhere on digital channels should there be information that could be construed as the promotion of prescription medicines, and there should be a disclaimer advising the public that the information available is not intended as substitute for a consultation with a health professional. As regards prescription medicines, the IPHA advise against the launch of digital platforms using prescription medicine names or trademarks unless specifically intended only for healthcare professionals.
Furthermore, it advises that companies should have clear policies in place regarding the use of social media by employees. In respect of inquiries received from healthcare professionals about the product(s), responses via digital channels are only acceptable if in line with the Pharmaceutical Code. Promotion of products via electronic data communications is prohibited unless with prior permission or at the request of the recipient. In certain circumstances, it may be acceptable to contact patients through social media channels e.g. to remind them to take their prescribed medication if there is documented approval form the healthcare professional and the patient, and the material is only for the purposes of supporting patient compliance.
20. May medicines and devices be advertised or sold directly to consumers?
Yes, medicines and devices can be advertised or sold directly to consumers subject to the restrictions outlined in Questions 17, 18 and 19. Consumers are only able to purchase non – prescription only medicines over the counter (OTC) and can only obtain prescription only medicinal products with a prescription from a licensed prescriber.
21. How is compliance monitored?
The advertising and marketing of medicinal products and medical devices is governed by self – regulatory industry codes which supplement the relevant Irish and EU legislation. Under Section 26, Part 6 of Statutory Instrument 541 of 2007, there is approval for the role of self-governing industry codes.
The HPRA also plays a vital role in regulating and monitoring compliance with the legislation by undertaking randomised reviews of advertisements in medical journals, newspapers, radio, television and on social media. It can also carry out inspections of the offices of MAH companies that advertise human medicinal products in Ireland. Further, the HPRA investigates any complaints they receive in relation to advertisements.
An intra-Industry complaint may be investigated by the ASAI where the interests of consumers are involved, but the ASAI has the discretion to decide to investigate or refer the complaint to a more appropriate body such as the HPRA.
The IPHA has a role in monitoring compliance with the Pharmaceutical Code and, if there are any breaches, the Code Council will generally investigate these. The IPHA can also however, refer complex or persistent breaches to the Minister for Health, and advise the ASAI of any findings it has made against an advertiser and recommend further action.
22. What are the potential penalties for noncompliance?
There are numerous potential penalties for non-compliance with advertising legislation and codes. The HPRA can order companies to withdraw misleading advertisements and to issue corrective statements where they have published a misleading advert. These decisions can be appealed via the courts process. Where the IPHA consider that an advert is not in the interest of public and consumer safety, they can request a withdrawal of the advert. Additionally, if a company is convicted under the Irish Medicines Board Act 1995, the Courts can order a withdrawal of the advert and request issuance of a corrective statement where they are satisfied that the advert was misleading.
The IPHA has an established Code Committee and they deal with any advertising complaints by examining complaints in detail to establish which clauses of the Code of Standards have been breached. The penalties they can impose range from reprimands, publication of their decision, suspension or expulsion of the company in breach from the IPHA, referral to the Minister, publication of a corrective statement, and suspension or expulsion from the IPHA.
A breach of the Advertising Regulations can incur penalties including of fines of up to €2,000 and/or imprisonment of up to 12 months on summary conviction, a fine of up to €120,000 and/or up to 10 years imprisonment on indictment. If there are subsequent convictions, the maximum fine imposed can be up to €300,000. If an offence is committed by a body corporate with the consent, connivance or by the negligence of a director, manager or other officer if the body corporate, that person may be personally liable. Prosecutions in relation to non-compliant advertisements can be brought by the PSI, the HSE, the Minister for Health and the HPRA.
If there is a breach under the Consumer Protection Act 2007 (CPA) and the Misleading Advertising Regulations, the penalties that can be imposed include a fine of up to €3,000 and/or imprisonment not exceeding 6 months on summary conviction, and a fine of up to €5,000 and/or imprisonment not exceeding 12 months for subsequent summary convictions. Where there have been convictions on indictment, a fine of up to €60,000 and/or imprisonment of up to 18 months or a fine of up to €100,000 and/or imprisonment of up to 24 months. for subsequent convictions. This amount can increase by €500 per day that the breach continues up to a maximum of €100,000.