EU- Directive “Falsified Medicines”

Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use

Questionnaire for Customers of E-Pharma Trento S.p.A.

In order to have a clear status of our Customer’s Requirements and to correctly define the URS (User Requirement Specification) of our future system we kindly ask you to answer the questions as below.

COMPANY

COMPANY NAME:

CONTACT PERSON, FUNCTION:

CONTACT PERSON e-mail:

SERIALIZATION

• Have you already defined a Company approach regarding the serialization requirements?

Yes No

• In case the answer to question 1. is NO, when will you be able to define the Company’s approach?

• In case the answer to question 1. is YES, what is your Company’s approach?

provide the serial numbers centrally to E-Pharma and perform the data upload to the European HUB

completely delegate the creation of the serial number and the upload of the data to the EU-HUB to E-Pharma

provide the methodology of creation of the serial number and delegate the upload of the data to the EU-HUB to E-Pharma

• In case the answer to question 3. is the first, how do you intend to provide the serial number to E-Pharma?

• What are your technical integration requirements, including transaction interface specifications?

• Have you chosen a technical partner for the traceability system?

No Yes, name:

• Have you already defined the Product code (GTIN/PPN/NTIN)?

Yes No

• Your requirements regarding the quality of the printing are only those prescribed in art. 6 of Commission Delegated Regulation (EU) 2016/161?

Yes No

• Your requirement regarding the serialization are only those prescribed by the Commission Delegated Regulation (EU) 2016/161?

Yes No

• Explain the levels of aggregation hierarchy you want us to support for each product
(e.g. X blisters in a folding box, Y bottles/folding boxes in a shipping carton, Z shipping cartons on a pallet).

• Please, list below the products and the Country involved:

	Name of the products	Country where product is distributed	Implementation deadline
1
2
3
4
5
6
7

TAMPER EVIDENCE

• Has your Company defined the optimal anti-tampering device?

Yes No

• In case the answer to question 1. is YES, what is your Company’s preference?

labels glue other:

• In case the answer to question 1. is NO, when will you be able to define the Company’s preference?

SUBMIT

• Notes