Q&A

When is falsified medicine/counterfeit drugs defined?

EU legislation and Danish legislation define falsified medicines as any medicinal product with a false representation of:

• – Identity – packaging, labelling, name and composition
• – Source – marketing authorization holder, manufacturer or country of origin
• – History – the records and documents relating to the distribution channels used

Examples of falsified medicines:

• – Medicines that have been illegally repackaged
• – Stolen medicines that are subsequently sold illegally in the legal chain

Medicines must be distributed via the legal supply chain, e.g. between companies authorized to distribute medicines

Any falsified medicines found on the Danish market?
In a few cases medicines have been withdrawn from the legal chain due to the risk of falsification and for safety reasons. In addition falsified medicines have been sold via illegal websites in Denmark and medicines have been imported illegally by private persons who have purchased medicine on foreign websites not holding an authorization.

What does the EU do to prevent counterfeit drugs on the market?
An EU directive on falsified medicines was adopted in 2011. Among other things, the directive introduces:

• – Stricter rules for the distribution of medicines in the EU/EEA
• – Stricter rules for the import and distribution of API used in marketed human medicinal products
• – Requirement that medicine packages of certain products are labelled with a unique code
• – Obligation that all websites in the EU/EEA with an authorization to sell medicinal products display a common approval logo on the website.

What does the industry do?
Pharmaceutical companies are working closely together in a network with relevant authorities, industry organizations and stakeholders, which work closely together on issues of falsified medicines. medicines. The work includes exchange of information on the area and joint solutions like serialization.

EU GMP Vol. 4, Annex 15, was last updated in 2001 and since then demands are increasing and includes risk assessments according to the ICH guidelines Q8, Q9, Q10 and Q11 and the EU GMP Eudralex, Vol. 4, Chapter 1.

EMA has worked for a long period, updating the EU GMP Annex 15 to ensure the requirements for validation and qualification harmonize with the ICH guidelines as well as with the new CHMP guideline for process validation.

Annex 15 has become more detailed and includes actual requirements for URS, FAT, verification of transport of medicine, validation of packaging processes, validation of utility systems plus validation of test methods. In addition, new validation concepts, Critical Process Parameters (CPP) and Critical Quality Attributes (CQA) have been introduced. The most severe change is the implementation of risk assessment throughout life cycle of the medicine, the equipment and the facility (lifecycle approach).

It can be very hard to see, as counterfeit medicines often are very good replicas of the original product. The counterfeit drugs are sent around both inside and outside the EU, through thoughtful and complex systems, which often makes it difficult to find the perpetrators.

Your company must react upon any irregularities in relation to whom you receive the drugs from and/or if your company is offered a very unusual price for the medicines that no one else in the market can match.

Although you have both the original and the counterfeit pharmaceutical drug next to each other, it’s very distinct differences that determine which product is the original one. More and more MAH now uses special protections on their products like special primary or secondary packaging and/or special holograms on the packaging material.

Both GMP and GDP companies are obliged to have a system to ensure proper handling of counterfeit drugs according to the Danish GMP and GDP Executive Order. If anyone in your company suspects counterfeit drugs, you are obliged immediately to contact the DHMA.

Flere og flere GMDP virksomheder har implementeret ISO 9001 standarden for at effektivisere deres kvalitetssystem. GMP reglerne giver rammerne bl.a. ved at stille krav til hvilke dokumenter m.m. der skal være i et givent kvalitetssystem, mens ISO reglerne giver jer værtøjer til at sikre et effektivt kvalitetssystem gennem løbende forbedringer.

GxP-Pharma Support A/S kan ikke komme med direkte anbefalinger, før vi kender mere til jeres virksomhed inkl. størrelse, processer og kompleksitet. Det er vores erfaring, at det er en stor opgave, som kræver en velfungerende, tværorganisatorisk projektorganisation samt tilstrækkelige ressourcer.

GxP-Pharma Support A/S står gerne til rådighed for yderligere information og vejleding med henblik på evt. implementering.

Ja, det kan man godt, men der skal foreligge en detaljeret kontrakt med information om, hvilke opgaver den pågældende person skal varetage og i hvilket omfang i forhold til daglig drift. Man kan dog ikke uddelegere det overordnede ansvar, kun opgaverne.

Kontrakten skal være underskrevet af begge parter med dato og signatur, for at være gældende i forhold til Sundhedsstyrelsens krav og forventninger.

Det forventes, at I som virksomhed har kendskab til risikovurdering og anvender det i dele af jeres kvalitetssystem. Risikovurdering er nævnt flere steder i de enkelte kapitler i den ny GDP vejledning.

Der er flere forskellige risikomodeller, man kan anvende. Vores erfaring er dog, at de simple modeller som regel er lettere at forstå for alle brugere og dermed lettere at gå i gang med, i det omfang man ikke i forvejen kender til modeller og begreber indenfor risikovurdering.

For at få tilstrækkelige kompetencer, anbefales det at sende minimum 2 medarbejdere på kursus samtidig, idet risikovurdering bliver bedst, når det udføres i et team og der skal som regel lidt øvelse til, før man bliver helt fortrolig med metoderne.

I det omfang der er behov for ekstern rådgivning eller assistance indenfor risikovurdering, er I velkomne til at kontakte GxP-Pharma Support A/S.