Marketing Authorisation Number
HALMED is Allocating the Marketing Authorisation Number
The Agency for Medicinal Products and Medical Devices (HALMED), under the Medicinal Products Act (Official Gazette, No. 76/13, 90/14, 100/18, and 136/25.) has been allocating the Marketing Authorisation Number since 15 July 2014.
Procedure for Allocating the Marketing Authorisation Number
HALMED assigns a Marketing Authorisation Number during the procedure for granting a marketing authorisation for each medicinal product it authorises.
The Marketing Authorisation Number remains the same and does not change during a variation, renewal, or transfer of the marketing authorisation.
Marketing Authorisation Number Layout and Characteristics
The Marketing Authorisation Number is composed of a 9 digit number, whereby 8 digits are determined by a random selection of numbers, whereas the 9th digit represents the control number calculated according to ISO 7064 (MOD 11, 10). The procedure of obtaining control digits is described below.
The Marketing Authorisation Number will not be changed during the entire life cycle of the medicinal product, regardless of changes to the medicinal product data (i.e. medicinal product name, marketing authorisation holder, manufacturer etc.).
A key characteristic of the Marketing Authorisation Number is its uniqueness; there is no medicinal product with the same number as the other one and there is no medicinal product with more numbers. In case the marketing authorisation has been revoked, its Marketing Authorisation Number will not be reallocated to a new product.
In addition, each individual packaging of the same medicinal product will have a numerical follow-up code from 01 to 99), enabling differentiation between various packagings of the same product, the so-called packaging sign. The Marketing Authorisation Number including the packaging sign represents the Marketing Authorisation Number for Packaging. In case of packaging deletion, the sign allocated to that packaging will not be reassigned to any other (existing or newly added) packaging.
Marketing Authorisation Number Layout example
HR-H-716058219 = Marketing Authorisation Number
HR-H-716058219-01 = Marketing Authorisation Number for Packaging
Description of individual digits:
- HR: country code
- H: field code (H=human medicinal products)
- 716058219: unique number at the level of the medicinal product/strength/pharmaceutical form
- 01-packaging code (indicated only on the packaging and does not count to the calculation of the control digit)
Procedure for Obtaining Control Digit
- The first digit is added to number 10
- The resulting whole number sum (with fractional) is divided by 10; if the obtained fractional is 0, it is replaced by 10 (this number is so-called inter-fractional)
- The obtained inter-fractional is multiplied by 2
- The obtained whole number product (with fractional) is divided by 11; this fractional cannot be mathematically 0, hence the result from the previous step is always an even number.
- The next digit is added to the fractional from the previous step
- Steps 2, 3, 4 and 5 are being repeated as long as all digits have been exhausted
- The difference between number 11 and the fractional in the last step is the control digit
Example of the Marketing Authorisation Number: 716058219 security check
For security check, the prefix HR-H should be omitted
| Step | Digit | Sum of the column b with the fractional from the previous step (number from the column f) or with number 10 for the first step | Fractional from division of the number from the column c by the number 10 - if it is 0, 10 is allocated | Product of the number from the column d with the number 2 | Fractional from dividing the number from the column e |
|---|---|---|---|---|---|
| a | b | c | d | e | f |
| 1 | 7 | 17 | 7 | 14 | 3 |
| 2 | 1 | 4 | 4 | 8 | 8 |
| 3 | 6 | 14 | 4 | 8 | 8 |
| 4 | 0 | 8 | 8 | 16 | 5 |
| 5 | 5 | 10 | 10 | 20 | 9 |
| 6 | 8 | 17 | 7 | 14 | 3 |
| 7 | 2 | 5 | 5 | 10 | 10 |
| 8 | 1 | 11 | 1 | 2 | 2 |
11-2=9; the control digit is number 9
How HALMED Informs Marketing Authorisation Holders About the Allocated Marketing Authorisation Number?
HALMED indicates the allocated Marketing Authorisation Number in the marketing authorisation, or the renewal of the marketing authorisation.
The Marketing Authorisation Number and the Marketing Authorisation Number for Packaging are listed in the marketing authorisation next to each individual packaging.
The Marketing Authorisation Number and the Marketing Authorisation Number for Packaging are displayed in the Medicinal Product Database available on the HALMED website.
Marketing authorisation holders are required to use the allocated Marketing Authorisation Number in their further communication with HALMED.
Marketing Authorisation Number in the Summary of Product Characteristics
The Marketing Authorisation Number is indicated in the Summary of Product Characteristics under section 8 (without the Marketing Authorisation Number for Packaging).
On the outer packaging, and on the inner packaging if the medicinal product has no outer packaging, the Marketing Authorisation Number for Packaging should be indicated.
