Information & Monitoring

Packaging and Labelling

Most medicines require packaging and labels in a prescribed format. There are detailed rules, setting out EU-wide standards on packaging and labelling. Very specific information is required on the label dealing with matters such as

• the name,
• pharmaceutical strength,
• qualitative and quantitative details of active ingredients,
• form and content by weight,
• list of recipients with the recognised effects,
• method of administration,
• warnings,
• expiry dates,
• storage requirements,
• disposal requirements,
• marketing authorisation,
• number and batch
• manufacture batch number.

On smaller packaging, labelling requirements are reduced,  provided they are supplied in outer packaging labelled with full requirements. Smaller immediate packaging would only include more limited details, including expiry date, match, name, and market authorisation, unless the details may be included.

Leaflets

The package leaflets, supplied with the medicine, must conform with specific requirements. It must include information in relation to identification, therapeutic indications, list of key information, necessary instructions for use, description of adverse reactions, expiry date, with relevant warnings on use. The contents of the leaflet must reflect the user testing, must be legible and clear and easy to use.

The authorisation holder must provide package leaflets on request from patient organisations in a form suitable for the blind and partly sighted.

Homeopathic Medicines

Homeopathic medicines must be labelled as such and must contain specific particulars, including

• scientific name,
• details of registration holder,
• expiry date,
• method of administration,
• pharmaceutical form,
• contents and sales presentations,
• warnings,
• storage precautions,
• registration numbers,
• warning regarding absence of therapeutic indications,
• warning to consult doctor if symptoms persist.

Medicines Classification

Medicines are classified in accordance with EU-derived regulations. There is broad classification between prescription and non-prescription medicines. Prescription status is assigned to products, which

• are likely to present a danger either directly or indirectly to human health when used incorrectly,
• frequently or to a wide extend used incorrectly, so as to present a direct or indirect danger to health,
• contains certain substances with adverse reactions,
• most injectable product.

A range of other factors are considered including international conventions, etc.

Pharacovigilance

Pharmacovigilance involves the  continued monitoring of products through its life cycle. The legal framework is set out in the EU regulations. A person placing a medicine in the market must have a qualified person for pharmacovigilance.

They must keep details of suspected adverse reactions and file them with the European Medical Authority and Irish regulator. They must submit details of all adverse reactions that come to their attentions. They must collect additional pharmacovigilance information.

Holders of marketing authorisations and certificates must monitor all new information regarding the product that comes to light. There are EU-based obligations relating to pharmacovigilance,

• updating information,
• keeping records of adverse reactions, and making them available to the regulator,
• keeping records to facilitate recalls,
• updating information on the product’s dossier,
• taking account of scientific and technological progress,
• notifying the regulator of any prohibitions or restrictions placed on the product in other countries and of new information which might affect the evaluations of risks and benefits,
• providing the regulator with data on the volume of sales and prescriptions, notifying the regulator of the placing on the market of the product,
• inform the regulator of any defects that could result from recall or abnormal restrictions.