Pharma Serialisation: A New Challenge for the …

1 Pharma serialisation : A New Challenge for the Industry The process to introduce serialisation in the packaging lines is very complex and needs an important investment to print, read and verify the serial numbers. An appropriate procedure for handling exceptions, reworks, returns and any other issues is also a must. Very few Pharma companies have already prepared their lines and processes to introduce serialisation and, as this requirement is no longer avoidable, reliable packaging suppliers will support their customers introducing serialisation as a new part of their process.

2 Innovative packaging suppliers must have the capability to adapt their PACKAGING94 INTERNATIONAL PHARMACEUTICAL INDUSTRY Supply chain synergies the unique code of each package can be accessed by pharmacists, the brand owner, officials or even consumers, providing the ability to track and trace products along the chain, from the Pharma facility to the consumer s protection fight against counterfeiting is a very big Challenge for healthcare authorities and Pharma companies. serialisation , as well as other anti-counterfeiting measures, will be a useful tool to reduce the impact of this problem.

3 Know and manage serial number definitions and the quality standards to take care and inform of every single loss of a batchIntegrate the serialisation procedures in the IT systems, for associating serial numbers with orders, shipments, invoices, etc. Source: HDMA, with serialisation equipment, and have the knowledge and experience to work properly with databases and different codification standards. The process to become a packaging supplier with the capability to serialise carton boxes brings some important challenges for the whole organisation, as serialisation enforces a traceable production process, controlling and reducing production losses.

4 serialisation does not only consist of printing a code on a box, but leads to a deeper collaboration between the packaging supplier and the pharmaceutical company. To be part of the serialisation process, the packaging supplier has to:Meanwhile, serialisation regulations are pending in developed countries (US, Canada and EU), and have already been implemented in several other countries like Turkey, India, China, Brazil, Argentina and South Korea. Brazil launched a three-year roll-out for Track & Trace requirements in 2009. In India regulations went into effect in the middle of 2011, and a barcode is mandatory on every medicine that will be exported from this country.

5 On the other hand, since 2010 China mandated printing a drug supervision code on the smallest package by March member of the industry knows the benefits of Serialisation: serialisation in the pharmaceutical industry is becoming a very important Challenge , not only for the manufacturers but also for their packaging suppliers. According to the Directive 2011/62/EU, Pharma companies have three years to implement a successful strategy in all their products to be distributed in the European Union. Similar regulations are in place today in India, China, Turkey and some other / Summer 2013 Volume 5 Issue 2 PACKAGING96 INTERNATIONAL PHARMACEUTICAL INDUSTRY In Europe, several countries have their own drugs, in addition to those pending from the EU.

6 However, in 2006, EFPIA (European Medicines Verification System) in collaboration with GS1, the global organisation dedicated to the design of global standards and solutions to improve efficiency and visibility in the supply chain, recommended the adoption of a unique standard for the coding of pharmaceutical product across Europe, based on the 2D (2-Dimensional) Data Matrix ECC-200, to be introduced on all secondary packaging of prescription products sold in Europe. While other coding standards, such as the PPN1, are available, EFPIA recommends the globally used GS1 standard.

7 EFPIA considers this the most effective and technological system for the current time. Despite this, the adoption of a 2D Data Matrix system does not mean that in the future, the adoption of other technologies such as RFID (Radio Frequency Identification) at a later stage will be a solution. In fact, nowadays, RFID costs double the amount and is not easy to introduce and operate, but it would probably be a natural progression of the system. EFPIA knows that national numbers in specific situations are needed, and have worked with GS1 to deliver an enhancement to the GS1 General Specifications that allows the accommodation of national product identifiers.

8 In a number of countries in Europe, these national numbers are used to facilitate the reimbursement processes and are embedded into IT systems, business processes and even legislation; it would present significant challenges for these countries to move to a GTIN. GS1 have therefore issued an amendment to the General Specifications that describes how these national codes can be accommodated. This code structure would make use of the Application Identifiers (AI) already in use throughout the supply chain today. The EFPIA preferred structure uses only four of the many Application Identifiers available to define: 1.

9 The product code. 2. The serial number. 3. The expiry date. 4. The lot number (batch code).The serial number will be unique per product code and should preferably only contain either lower case or upper case letters, not a mixture. On the other hand, the alphanumeric range can include the digits 0-9 and the letters of the western alphabet, but excludes the following letters: i, j, l, o, q and u (I, J, L, O, Q and U). In order to provide a reasonable level of complexity within the serial number, the probability that a valid serial number Source: 2D Data Matrix ECC-200 can be guessed should be a minimum of 1 in 10,000.

10 Therefore, in order to avoid the opportunity for a counterfeiter to estimate the randomisation pattern from two or more samples, two aspects will be taken into account: On the other hand, the so-called National Healthcare Reimbursement Number (NHRN) is usually assigned by a national authority to healthcare brand owners for specific trade items, and should only be used for compliance to regulatory requirements where the GTIN alone in a barcode symbol will not meet the requirements. When a regionally-specific NHRN application identifier is approved (as above), the overall variable length is specified by the national authority, with a twenty alpha-numeric characters maximum, as noted in the general format above if applicable.