Serialization –introducing safety features on the packaging of medicinal products
The presence of falsified medicinal products has been increasing worldwide in recent years. Purchasing medicinal products on the black market can be very dangerous for patients because in most cases the origin of these products is unknown, their quality is questionable and often they are falsified medicinal products that can seriously endanger the health of patients.
Falsified medicinal products do not undergo stringent requirements for quality, safety and efficacy assessment required by EU procedures for granting marketing authorization. They can be harmful to patients’ health or even cause death.
When we talk about the risk of falsified medicinal products, serialization implies marking each individual medicinal product packaging with a serial number in order to protect consumers from falsified medicinal products that are becoming increasingly threatening along with advances of the Internet and mobile technology.
There are two safety features that should be placed on the packaging of medicinal products:
- Unique identifier (UI) consisting of a series of numbers or alphanumeric characters which is unique to each packaging and allows for the authentication and identification of a single package of medicinal products.
- Anti-tampering device (ATD) to check whether the medicinal product packaging has been opened or altered from the moment it has left the manufacturer’s facilities.
The manufacturer places them on the outer packaging of the medicinal product, thereby allowing the identification and authentication of each packaging on which these features are placed.
This technological solution should stop the sale of suspicious medicinal products over the Internet and enable the monitoring of distribution from the manufacturer to the patient, either through hospitals or pharmacies.
The procedure is demanding in a financial and regulatory sense but it will ensure better business protection against loss of profit and, most importantly, a better public health protection by providing only safe medicinal products available to consumers.
Iva Antunović Kršić, VMD / Deputy head of Drug and Medical Devices registration department
Lašćinska cesta 40
Planinska ulica 13/2
Office: +385 1 5588 297
Pharmacovigilance: +385 1 5588 297
Clinical trials: +385 1 5614 330
Registration: +385 1 242 0873
Marketing: +385 1 2420 890
Fax: +385 1 2420 860
Tel: +385 1 5588 297
Full company name
Short company name
Marti Farm Ltd. Trade and Services
Marti Farm Ltd.
Lašćinska cesta 40, HR-10000 Zagreb
Planinska ulica 13/2, HR-10000 Zagreb
a limited liability company
Commercial Court of Zagreb
HRK 20,000.00 (paid in its entirety)
Martina Diminić Smetiško, director of the
company (Representing the company
individually and independently, Responsible
person for data protection)
HR3623600001102197724 (Zagrebačka banka)
HR4324020061100628669 (Erste banka)
Full company name: Marti Farm Ltd. Trade and Services
Short company name: Marti Farm Ltd.
Headquarters: Lašćinska cesta 40, HR-10000 Zagreb
Office: Planinska ulica 13/2, HR-10000 Zagreb
Legal form: a limited liability company
Court register: Commercial Court of Zagreb
Registration number: 080751121
Share capital: HRK 20,000.00 (paid in its entirety)
Authorized representative: Martina Diminić Smetiško, director of the company (Representing the company individually and independently, Responsible person for data protection)
Bank account: HR3623600001102197724 (Zagrebačka banka), HR4324020061100628669 (Erste banka)