CROSS-BORDER PRESCRIPTION IN PAPER FORM

A cross-border prescription is a document that enables the purchase of a medicinal product classified under the availability category POM (prescription-only medicines), issued in an EU/EFTA Member State by a person authorised under that country’s national regulations. It can be filled in another Member State under the conditions established by the legislation of that country, in accordance with the principle that cross-border healthcare must respect the national law of the country where the service is provided. Therefore, when dispensing the medicine, the pharmacist must apply the local regulations, which may, for example, limit the number of doses to be dispensed or set out the validity periods of prescriptions.

A person filling a cross-border prescription in Poland is therefore subject to Polish regulations governing the filling of prescriptions. As a general rule, the prescription should be filled within 30 days from the date of issue. However, certain exceptions apply — for example, a prescription for an antibiotic is valid for only seven days.

There is no specific standardized format for a cross-border prescription. As a result, the prescription will follow the design and requirements of the country in which it was issued. Nevertheless, the prescriber is required to include in it all the information necessary for cross-border dispensing.

Since a cross-border prescription is issued only at the request of a patient intending to fill it in an EU/EFTA Member State other than their country of insurance, the prescriber must ensure that the document meets at least the minimum requirements set out in the Directive 2012/52/EU.

A cross-border prescription is always filled at full cost — the patient must pay the full price of the medicine at a Polish pharmacy. Upon returning to their country of insurance, the patient may apply to their insurer for reimbursement under the provisions of the Cross-Border Healthcare Directive (CBHD). Reimbursement will be granted if the medicine is covered by the national health insurance system.

A person filling a cross-border prescription at a Polish pharmacy may be asked to present an identity document if there is a suspicion that they are underage (i.e., 13 years old, in cases where the dispensing of the medicinal product is subject to age restrictions) or if the personal data on the prescription are illegible.

Restrictions

At a Polish pharmacy, cross-border prescriptions cannot be filled for the following categories of medicinal products:

• controlled substances, including narcotic and psychotropic drugs
• compounded prescription medicines
• restricted-use prescription medicines
• foodstuffs for particular nutritional uses
• medical devices

DATA REQUIRED ON CROSS-BORDER PRESCRIPTIONS
A cross-border prescription in paper form must contain at least:

• Details of the person for whom the prescription was issued:

• • name and surname written in full (initials are not permitted)
  • date of birth

• Details of the healthcare professional who issued the prescription:

• • name and surname written in full (initials are not permitted)
  • professional qualification
  • contact details (email and telephone or fax including international prefix)

• Details of the place of service provision:

• • address including the country

• Details of the prescribed product including dosage and instructions for use:

• • common name
  • brand name and a brief statement of the reason if:

- the prescribed medication is a biological medicinal product
or
- a specific brand is medically necessary

• • pharmaceutical dosage form
  • strength
  • quantity
  • dose regimen

• Authentication of the prescription:

• • date of issue
  • handwritten signature

More information on cross-border prescriptions:

https://europa.eu/youreurope/citizens/health/prescription-medicine-abroad/prescriptions/index_en.htm

CROSS-BORDER e-PRESCRIPTION

Cross-border e-prescription is a service that enables the purchase of a medicinal product classified under the availability category POM (prescription-only medicines) based on the electronic transfer of medical data between EU/EFTA countries participating in the e-prescription exchange system.*

Poland was one of the first countries to launch the e-prescription exchange system (in September 2020).

Currently in Poland it is possible to fill cross-border e-prescriptions issued in nine EU countries:

• Czech Republic
• Finland
• Latvia
• Lithuania
• Estonia
• Croatia
• Portugal
• Greece
• Spain (applies to pharmacies in Madrid, the Canary Islands, the Basque Country, Catalonia, Extremadura, Aragon, Castilla y León, Andalusia, the Community of Valencia and Cantabria)

The exchange of e-prescriptions with Hungary and Cyprus is under development.

* For a list of EU/EFTA countries that do not participate in the e-prescription exchange system, see the Public Information Bulletin (BIP) of the Ministry of Health.

A cross-border e-prescription, just like a traditional paper prescription, must be issued by a person authorised under the regulations of their respective EU/EFTA Member State. It can be filled in another Member State under the conditions established by the legislation of that country, in accordance with the principle that cross-border healthcare must respect the national law of the country where the service is provided. This means that, when dispensing the medicine, the pharmacist must apply the local regulations, which may, for example, limit the number of doses to be dispensed or set out the validity periods of prescriptions.

In order to process an e-prescription in Poland, it is necessary for the patient to give prior consent for the handling of e-prescriptions in accordance with the regulations applicable in the country of issue. Detailed information on this requirement is provided by the national contact points.

A cross-border e-prescription, just like a traditional paper prescription, is always filled at full cost — the patient must pay the full price of the medicine at a Polish pharmacy. Upon returning to their country of insurance, the patient may apply to their insurer for reimbursement under the provisions of the Cross-Border Healthcare Directive (CBHD). Reimbursement will be granted if the medicine is covered by the national health insurance system.

A person filling a cross-border prescription at a Polish pharmacy may be asked to present an identity document to confirm their identity, as an e-prescription cannot be filled on behalf of a third party.

Before processing a cross-border e-prescription, the pharmacist is obliged to provide the patient with information on the processing of their personal data and ensure that the patient has read and acknowledged this information.

Restrictions

• at a Polish pharmacy cross-border e-prescriptions cannot be filled for the following categories of medicinal products:

• • controlled substances, including narcotic and psychotropic drugs
  • compounded prescription medicines
  • restricted-use prescription medicines
  • foodstuffs for particular nutritional uses
  • medical devices

• may only be issued for a patient over 18 years of age
• no possibility to dispense a medicine with a different strength or dosage form
• no possibility of partial dispensing of the prescription
• no possibility of dispensing to a third party
• no possibility of dispensing in the event of system failure

DATA REQUIRED ON CROSS-BORDER e-PRESCRIPTIONS

• prescription identifier
• date of issue
• patient’s first name and surname
• patient’s personal identifier
• patient’s date of birth
• patient’s gender
• patient’s country of affiliation
• prescriber’s first name and surname
• prescriber’s personal identifier (Healthcare Provider Identifier – HCPI)
• address of the issuing facility
• information on the prescribed medicine:

• • common name
  • product identifier
  • active ingredient(s)
  • strength
  • number of units per package
  • type of packaging (if available)
  • pharmaceutical dosage form
  • name of the manufacturer (if available)
  • route of administration (if available)
  • quantity (number of packages)
  • marketing authorisation holder (if available)

• information on whether the substance is authorised (if applicable)
• dose regimen
• directions for use (if applicable)
• advice for the dispenser (if applicable)
• details of the entity responsible for personal data recorded in the e-prescription
• digital signature

If the there is no note explicitly excluding such a possibility, the pharmacist may offer to dispense a medicinal product with an equivalent composition and effect (a substitute).

More information on cross-border e-prescriptions:

• https://europa.eu/youreurope/citizens/health/prescription-medicine-abroad/prescriptions/index_pl.htm
• https://ec.europa.eu/assets/sante/health/pins/poland/poland_epa_polish.pdf