All the essential information that helps a patient to use a prescription medicine correctly and safely must be provided on the package labelling. The information must be in Finnish and Swedish.
Labelling for professionals makes it possible to identify the correct product throughout the supply chain and to combat falsified medicines.
What information must appear on the outer packaging of a prescription medicine?
Mandatory information includes the trade name of the medicinal product, the name of the active ingredient and its strength in micrograms or milligrams, for example. The mandatory information also includes the form of the pharmaceutical: is it a tablet or capsule. The outer packaging must also include information on the package size – for example, 100 tablets.
The method of administration must also be provided, specifying, for example, if the product is injected. If necessary, information on the route of administration must also be stated, such as an intramuscular or intravascular injection. Any excipients that may cause symptoms to the user must also be mentioned. These include lactose.
Certain warnings are mandatory for many medicines, such as whether the product is suitable for pregnant women. The red triangle is another of the warning labels: it shows that the medicine impairs reactions. When using a red triangle medicine, the user should avoid driving or using machinery that requires precision.
Other mandatory labelling includes the expiry date, usually the month and the year, and the storage instructions, such as whether the medicine should be kept refrigerated or, protected from direct light. The name and address of the marketing authorisation holder must be mentioned, as well as with the marketing authorisation number, batch number and Nordic product number.
In the case of veterinary medicines, the inner and outer package labelling and leaflet must indicate that the product is for animal use only. The outer package labelling must also specify the species of animal for which the product is intended.
Who decides what information must be provided on medicine packaging?
The authority determining both mandatory and permitted information on pharmaceutical packaging is the European Medicines Agency (EMA). National pharmaceutical authorities also add their own requirements; in Finland the national authority is the Finnish Medicines Agency Fimea.
The appearance of medicine packaging is also strictly specified. The marketing authorisation holder, such as Orion, first prepares the labelling and the appearance of its packages. These mock-ups are then submitted to the authority, which then approves them or requires changes to be made. Only once approval has been received can the medicine be produced for use.
Is braille a mandatory requirement on the outer packaging?
Information in braille is mandatory on all medicinal products for human consumption. This specific labelling requirement applies to both prescription and self-care medicines, that is, all medicines sold in pharmacies.
The mandatory information in braille includes the trade name, strength and pharmaceutical form of the medicinal product.
What information does the paper leaflet contain and is it worth reading?
The package leaflet contains clearly worded information in Finnish and Swedish for consumers. The user should read at least the beginning of the leaflet: what the medicinal product is, what types of symptoms or illness the medicine is used for and how it should be taken. It is also worth checking when the medicine should not be used or what side effects the medicine may cause – and what to do if you suspect you are experiencing an adverse effect of the medicine. It is also advisable to read the medicine’s storage instructions so that the medicine does not spoil because of incorrect storage.
If you are taking the medicine for the first time, it is a good idea to read the entire package leaflet carefully. It is also worth asking the pharmacist about the use of the medicine when picking up the prescription at a pharmacy.
Some medicines, such as asthma inhalers, come with special dispensing equipment. The user should be familiar with the correct use of the dispenser from the outset for the medicine to have the desired efficacy. This is why reading the user instructions is highly recommended.
The expert interviewed was Pernilla Holmqvist, Development Manager and Team Leader at Orion Pharma.
Text: Essi Kähkönen
24 January 2022