Commission Delegated Regulation (EU) 2016/161Show full title

CHAPTER II TECHNICAL SPECIFICATIONS OF THE UNIQUE IDENTIFIER

Article 4 Composition of the unique identifier

The manufacturer shall place on the packaging of a medicinal product a unique identifier which complies with the following technical specifications:

(a)

The unique identifier shall be a sequence of numeric or alphanumeric characters that is unique to a given pack of a medicinal product.

(b)

The unique identifier shall consist of the following data elements:

(i)

a code allowing the identification of at least the name, the common name, the pharmaceutical form, the strength, the pack size and the pack type of the medicinal product bearing the unique identifier (‘product code’);

(ii)

a numeric or alphanumeric sequence of maximum 20 characters, generated by a deterministic or a non-deterministic randomisation algorithm (‘serial number’);

(iii)

a national reimbursement number or other national number identifying the medicinal product, if required by the Member State where the product is intended to be placed on the market;

(iv)

the batch number;

(v)

the expiry date.

(c)

The probability that the serial number can be guessed shall be negligible and in any case lower than one in ten thousand.

(d)

The character sequence resulting from the combination of the product code and the serial number shall be unique to a given pack of a medicinal product until at least one year after the expiry date of the pack or five years after the pack has been released for sale or distribution in accordance with Article 51(3) of Directive 2001/83/EC, whichever is the longer period.

(e)

Where the national reimbursement number or other national number identifying the medicinal product is contained in the product code, it is not required to be repeated within the unique identifier.

Article 5 Carrier of the unique identifier

1. Manufacturers shall encode the unique identifier in a two-dimensional barcode.

2. The barcode shall be a machine-readable Data Matrix and have error detection and correction equivalent to or higher than those of the Data Matrix ECC200. Barcodes conforming to the International Organization for Standardisation/International Electrotechnical Commission standard (‘ISO/IEC’) 16022:2006 shall be presumed to fulfil the requirements set out in this paragraph.

3. Manufacturers shall print the barcode on the packaging on a smooth, uniform, low-reflecting surface.

4. When encoded in a Data Matrix, the structure of the unique identifier shall follow an internationally-recognised, standardised data syntax and semantics (‘coding scheme’) which allows the identification and accurate decoding of each data element of which the unique identifier is composed, using common scanning equipment. The coding scheme shall include data identifiers or application identifiers or other character sequences identifying the beginning and the end of the sequence of each individual data element of the unique identifier and defining the information contained in those data elements. Unique identifiers having a coding scheme conforming to ISO/IEC 15418:2009 shall be presumed to fulfil the requirements set out in this paragraph.

5. When encoded in a Data Matrix as data element of a unique identifier, the product code shall follow a coding scheme and begin with characters specific to the coding scheme used. It shall also contain characters or character sequences identifying the product as a medicinal product. The resulting code shall be less than 50 characters and be globally unique. Product codes which conform to the ISO/IEC 15459-3:2014 and ISO/IEC 15459-4:2014 shall be presumed to fulfil the requirements set out in this paragraph.

6. Where necessary, different coding schemes may be used within the same unique identifier provided that the decoding of the unique identifier is not hindered. In that case, the unique identifier shall contain standardised characters permitting the identification of the beginning and the end of the unique identifier as well as the beginning and the end of each coding scheme. Where containing multiple coding schemes, unique identifiers which conform to ISO/IEC 15434:2006 shall be presumed to fulfil the requirements set out in this paragraph.

Article 6 Quality of the printing of the two-dimensional barcode

1. Manufacturers shall evaluate the quality of the printing of the Data Matrix by assessing at least the following Data Matrix parameters:

(a) the contrast between the light and dark parts;

(b) the uniformity of the reflectance of the light and dark parts;

(c) the axial non-uniformity;

(d) the grid non-uniformity;

(e) the unused error correction;

(f) the fixed pattern damage;

(g) the capacity of the reference decode algorithm to decode the Data Matrix.

2. Manufacturers shall identify the minimum quality of the printing which ensures the accurate readability of the Data Matrix throughout the supply chain until at least one year after the expiry date of the pack or five years after the pack has been released for sale or distribution in accordance with Article 51(3) of Directive 2001/83/EC, whichever is the longer period.

3. When printing the Data Matrix, manufacturers shall not use a quality of the printing lower than the minimum quality referred to in paragraph 2.

4. A quality of printing rated at least 1,5 in accordance with ISO/IEC 15415:2011 shall be presumed to fulfil the requirements set out in this Article.

Article 7 Human-readable format

1. Manufacturers shall print the following data elements of the unique identifier on the packaging in human-readable format:

(a) the product code;

(b) the serial number;

(c) the national reimbursement number or other national number identifying the medicinal product, if required by the Member State where the product is intended to be placed on the market and not printed elsewhere on the packaging.

2. Paragraph 1 shall not apply where the sum of the two longest dimensions of the packaging equals or is less than 10 centimetres.

3. Where the dimensions of the packaging allow it, the human-readable data elements shall be adjacent to the two-dimensional barcode carrying the unique identifier.

Article 8 Additional information in the two-dimensional barcode

Manufacturers may include information other than the unique identifier in the two-dimensional barcode carrying the unique identifier, where permitted by the competent authority in accordance with Title V of Directive 2001/83/EC.

Article 9 Barcodes on the packaging

Medicinal products having to bear the safety features pursuant to Article 54a of Directive 2001/83/EC shall not bear on their packaging, for the purpose of their identification and verification of their authenticity, any other visible two-dimensional barcode than the two-dimensional barcode carrying the unique identifier.