Marketing Authorisation Number
HALMED is allocating the Marketing Authorisation Number
The Agency for Medicinal Products and Medical Devices (HALMED), under Medicinal Products Act (Official Gazette, No. 76/13) from 15 July 2014 starts allocating the Marketing Authorisation Number.
Procedure of allocating the Marketing Authorisation Number
The procedure of allocating the Marketing Authorisation Number will be carried out stepwise:
1. In the first place, HALMED will start allocating the Marketing authorisation Number to medicinal products, whose marketing authorisation procedure, or renewals finishes by this date.
2. The Marketing Authorisation Number will thereafter be allocated to medicinal products whose marketing authorisations have been granted or renewed before this date via variation procedure. Marketing authorisation holders will be informed about the beginning of this phase through HALMED's webpages.
Marketing Authorisation Number lay out 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 whole medicinal product life-cycle, regardless on changes in the medicinal product data (i.e. medicinal product name, marketing authorisation holder, manufacturer etc.).
The main Marketing Authorisation Number characteristic 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 In case the marketing authorisation has been revoked, its Marketing Authorisation Number will not be reallocated to a new product.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, every single medicinal product packaging of the same product will be a numerical follow up digit code from 01 to 99) facilitating to differentiate various packaging of the same product, so called packaging sign. The Marketing Authorisation Number with the sign represents the Marketing Authorisation Number for Packaging. In case of packaging deletion, the sign allocated to this packaging will not be allocated to some other (existing or newly added) packaging).
Marketing Authorisation Number lay out 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|
11-2=9; the control digit is number 9
How will HALMED inform marketing authorisation holders about the allocated Marketing Authorisation Number?
HALMED will indicate the allocated Marketing Authorisation Number in the marketing authorisation, or renewal of marketing authorisation.
The Marketing Authorisation Number and Marketing Authorisation Number for Packaging will figure on the marketing authorisation alongside every individual packaging.
The Marketing Authorisation Number and the Marketing Authorisation Number for Packaging will be viewable in the Medicinal Product Database which is accessible on the HALMED webpages.
Marketing authorisation holders are required to use the allocated Marketing Authorisation Number in their further communication with HALMED. Under Ordinance on granting marketing authorisation (Official Gazette, No. 83/13), the allocated Marketing Authorisation Number should be indicated in the applications for variation and renewal.
Marketing Authorisation Number in the Summary of Product Characteristics
The Marketing Authorisation Number is indicated in the Summary of Product Characteristics under Paragraph 8 (without indicating the Marketing Authorisation Number for Packaging).
On the outer and inner packaging, if the product has no outer packaging, the Marketing Authorisation Number for Packaging should be indicated.
If the Marketing Authorisation Number has been allocated to a medicinal product, the class of the Marketing Authorisation should no longer be indicated neither in the Summary of Product Characteristics, nor on the packaging.