Reporting requirements for defective productsGovernment notification
What requirements are there to notify government authorities (or other bodies) of defects discovered in products, or known incidents of personal injury or property damage?Consumer products
The GPSR requires producers and distributors to immediately inform the competent authorities of the member state in which the products in question are, or have been, marketed or otherwise supplied to consumers where they ‘know or ought to know’ that a product they have marketed is unsafe and does not satisfy the health and safety requirements that the product should satisfy (the general safety requirement).
The requirements to notify, in general, concern notification of information regarding defects or newly discovered risks, irrespective of whether any incident, injury or damage has yet occurred.Commercial products
There are currently no Irish statutory requirements requiring notification of defective commercial products to the authorities. The SHWAWA places an obligation on employers to report accidents and dangerous occurrences to the HSA. See the rules referred to in question 5 for specific sectors.
Where products have been tested or certified by a third party, it is possible there may be a contractual obligation incorporated into the agreement requiring the manufacturer or its representative to inform the body concerned.Notification criteria and time limits
What criteria apply for determining when a matter requires notification and what are the time limits for notification?Consumer products
Notification is required if the consumer product is known to have risks that are not compatible with the health and safety requirements that the product should satisfy. The relevant authority should be notified immediately once it is known that a product is unsafe.Food and drink
Obligations to inform the Food Safety Authority of Ireland (FSAI), the relevant authority in Ireland responsible for the monitoring of food on the Irish market, are governed by the General Food Law Regulations 2007 (as amended) and the Food and Feed Hygiene Regulations 2009 (as amended). An FBO must notify the FSAI if it believes that the food placed on the market is unsafe. A food product is considered unsafe if it is considered to be injurious to health or unfit for human consumption.Medical devices
The Health Products Regulatory Authority (HPRA) is the competent authority for medical devices in Ireland and has the responsibility for coordinating and recording details of incidents reported to them under the auspices of the vigilance system for medical devices.
The Medical Devices Directive 93/42/EEC places a mandatory obligation on manufacturers to report all incidents that occur in Ireland to the HPRA. An ‘incident’ is defined as:
an event that causes or has the potential to cause unexpected or unwanted effects involving the health and safety of patients, users or other persons.
Incidents that meet the following three criteria must be reported to the HPRA.An event has occurred
Typical events, for example, might include the following:
- device malfunction;
- unanticipated side effects;
- interactions with other substances or products; and
- inaccurate labelling.
Events could also include the outcome of an inspection or test or the receipt of scientific information.The device is suspected to have a contributory cause of an incident
In assessing this criterion, the manufacturer should consider the opinion of healthcare professionals, the results of the preliminary results of their own investigations and any evidence of similar previous incidents. The HPRA recommends that manufacturers err on the side of caution when considering this criterion.The event led, or might have led, to one of the following outcomes
- Death of a patient, user or other person; or
- serious deterioration in the state of health of a patient, user or other person.
Upon becoming aware that one of its devices has contributed to an incident, a medical device manufacturer must report the incident within the following timelines, based on the nature of the incident:
- serious public health threat: report immediately, but not later than two calendar days after awareness;
- death or unanticipated serious deterioration in the state of health: report immediately, but not later than 10 calendar days after awareness; and
- other: report immediately, but not later than 30 calendar days after awareness.
On 5 April 2017, two new European Regulations on medical devices were adopted and entered into force on 25 May 2017:
- Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No. 178/2002 and Regulation (EC) No. 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC; and
- Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU.
The new regulations strengthen the regulatory framework relating to medical devices, including the pre-market assessment of devices, postmarket surveillance and the transparency of data. The new rules will only apply after transitional periods of three years after entry into force for the Regulation on medical devices (May 2020) and five years after entry into force for the Regulation on in vitro diagnostic medical devices (May 2022).
The HPRA is in the process of drafting a detailed implementation plan for the two Regulations.Medicinal products
The Medicinal Products (Control of Placing on the Market) Regulations 2007 (as amended) state that a person must not place a medicinal product on the market unless authorised to do so. Manufacturing and marketing authorisation applications must include descriptions of the arrangements for the withdrawal or recall from sale, supply or exportation of any medicinal product to which the authorisation relates.
Notification to the HPRA for recalling classes of medicinal products can range from 24 hours for more serious risks, to within five days for less serious risks. For guidance, see the HPRA Guide for Recall of Medicinal Products for Human and Veterinary Use.Cosmetics
Under the Cosmetic Products Regulations 2013, it is prohibited to place a cosmetic product on the market that is liable to cause damage when applied under normal conditions of use or conditions of use that are reasonably foreseeable. If the product does not adhere to the requirements set out in the Regulation, notification must be made to the HPRA.Electrical equipment
The European Union (Making Available on the Market of Electrical Equipment Designed for Use within Certain Voltage Limits) Regulations 2016 require that electrical products placed on the market must have been constructed in accordance with the principles of good engineering practice in safety matters and do not endanger the safety of persons, domestic animals or property. If manufacturers have reason to believe that an endangerment is likely, they must inform the CCPC.Motor vehicles
Under the European Communities (Road Vehicles: Type-approval) Regulations 2009, manufacturers must ensure that, prior to placing new vehicles on the market, they must ensure that the vehicles are manufactured to prescribed safety and environmental standards. Manufacturers are responsible to the National Standards Authority of Ireland and the Road Safety Authority of Ireland (RSA), for all aspects of the approval process and for ensuring conformity of production.Toys
Under the European Communities (Safety of Toys) Regulations 2011 (as amended), it is prohibited to place a toy on the Irish market unless it is safe, has a CE mark (the CE mark on a product is an indication that the product meets the essential safety requirements of the relevant directives) and complies with essential safety requirements. If not, then notification must be made to the CCPC.Competent authority
To which authority should notification be sent? Does this vary according to the product in question?
For most consumer products, the appropriate authority for notifications in Ireland is the CCPC. For contact details, see www.ccpc.ie.
If the product is supplied across the EU, one single application can be made and the relevant national authorities will be informed of this. These authorities may forward the information notified to them to the EU authorities for the purposes of the Safety Gate - the rapid alert system for dangerous non-food products (RAPEX), Rapid Alert System for Food and Feed (RASFF) or other rapid alert systems in Europe for pharmaceuticals and medical devices, or for the purposes of information-sharing systems pursuant to other EU legislation.
Other bodies that monitor market safety of certain products include the following:
Health Products Regulatory Authority
Health Products Regulatory Authority
Health Products Regulatory Authority
Food Safety Authority of Ireland
What product information and other data should be provided in the notification to the competent authority?
The information required generally relates to the nature of the defect, the product affected and the action being taken to prevent the risk. Information enabling a precise identification of the product or batch of products in question, a full description of the risk that the products in question present, all available information relevant for tracing the product and a description of the action undertaken to prevent risks to consumers should also be provided when notifying the competent authority. Failure to comply with these requirements is a criminal offence.Medical devices
When notifying the HPRA of an incident, a manufacturer must complete the Manufacturer’s incident report form, which can be downloaded from the HPRA website and can also be obtained in the European Commission Guidelines on Medical Devices Vigilance system MEDDEV 2.12-1.Medicinal products
When reporting a quality defect to the HPRA, the following information must be provided:
- the exact name of the medicinal product;
- the product marketing authorisation number (PA/VPA/EU Number), if any;
- the product dosage form (eg, tablets) and strength (eg, 75mg);
- the batch or lot number;
- the expiry date;
- the name of the marketing authorisation holder;
- where the product was obtained (eg, the wholesaler or pharmacy name, and its address);
- an exact and full description of the suspected defect (as specific and as detailed as possible);
- name, address and contact details, including telephone numbers, of the person making the report; and
- the date on which the quality defect is reported.
Marketing authorisation holders, manufacturers and wholesalers should use the Quality Defect Report Form to report quality defects to the HPRA. This form is available on the HPRA website.Obligations to provide updates
What obligations are there to provide authorities with updated information about risks, or respond to their enquiries?
Distributors and producers should provide as much information as possible to the authorities when first requested to do so. If the information initially provided is incomplete, distributors and producers should provide further and complete information as soon as possible. As distributors and producers have a duty to cooperate with the authorities and to minimise risk to consumers, failure to provide the required information may amount to an offence under Irish law. The authorities also have formal enforcement powers to require the provision of additional information and records if they require it to investigate a breach of product safety legislation or to decide whether to use their enforcement powers to, for example, serve safety notices. Market surveillance authorities will have new and expanded powers under the proposed EU Regulation on Market Surveillance of Products. The draft regulation requires economic operators to make available on request any documentation or information that the surveillance authorities require.Penalties
What are the penalties for failure to comply with reporting obligations?
Failure to comply with the GPSR can result in a summary conviction to a fine not exceeding €3,000, or to imprisonment for a term not exceeding three months, or to both.
Under food law, penalties range from a fine not exceeding €5,000 or three months’ imprisonment for summary convictions, to a fine not exceeding €500,000 or a maximum three-year prison term for convictions on indictment. Motor-vehicle offences carry summary and indictable offences, ranging from a fine of up to €5,000 or six months’ imprisonment for summary offences, to a fine of up to €100,000 or a maximum of 12-month term of imprisonment. Offences relating to electrical equipment range from, on summary conviction, a fine not exceeding €5,000 or a maximum of six months’ imprisonment, to a fine not exceeding €500,000 or a maximum of two years’ imprisonment for indictable offences. Offences relating to toys can comprise, on summary conviction, a fine not exceeding €5,000 or a maximum of six months’ imprisonment, to a fine not exceeding €500,000 or a maximum of two years’ imprisonment for indictable offences.Public disclosure
Is commercially sensitive information that has been notified to the authorities protected from public disclosure?
The GPSR states that protection of professional secrecy will not prevent a company from disclosing to the CCPC information that is relevant to ensure the effectiveness of market monitoring and surveillance activities. The CCPC has a duty to ensure that the information received remains confidential.
The CCPC may make available to the public information relating to the risks to consumer health and safety posed by products, in particular information on product identification, the nature of the risk and the measures taken. If information is disclosed by the CCPC, which by its nature is confidential, other than information relating to the safety properties of any product that is disclosed in order to protect the safety and health of consumers, this will constitute an offence by the CCPC.
Under the Freedom of Information Act 2014 (FOIA), any person may request information from the authorities on a product safety matter. The original provider of the information has no right to prevent its disclosure. The authorities have discretion as to whether to release information that is provided in confidence or that could prejudice a person’s commercial interests.
The FOIA recognises that in many circumstances it may be inappropriate for a public body to disclose the information that it holds. The FOIA therefore contains a number of exemptions that protect information from potential disclosure. Of particular relevance to product safety notifications and recalls are those exemptions relating to ‘investigations’, ‘law enforcement’ and ‘information provided in confidence’.Use of information in prosecution
May information notified to the authorities be used in a criminal prosecution?
If a criminal prosecution were to ensue, it is likely that the information notified would be used in these proceedings.