What does the future hold for the pharmaceutical compliance market?
Regulatory pharmaceutical compliance means adhering to the laws and rules that are relevant to a company’s operations. This entails that a pharmaceutical company follow all applicable laws passed by a governing body and regulations established by a regulating entity.
The pharmaceutical business is heavily regulated due to the enormous effects that drugs and therapies can have on patients’ lives. Sales and marketing, drug pricing reporting, patient privacy, clinical operations, medical device testing, and manufacturing are just a few of the pharmaceutical operations that are subject to regulatory scrutiny. As a result, pharmaceutical compliance is given top priority by businesses. Noncompliance with regulatory requirements in the pharmaceutical industry can have substantial repercussions, including significant financial judgements and potential legal and criminal repercussions.
For this reason, we have decided to write an article about the upcoming regulations for several of the world’s most important countries when it comes to pharmaceuticals. Additionally, these are places that are sometimes left out when discussing these topics. Information on compliance is often oversaturated with American and European regulatory updates. However, pharmaceutical companies need to pay attention to the regulations of their respective countries.
United Arab Emirates
To protect patient safety, many nations have passed laws requiring life sciences and pharmaceutical firms to adhere to safety standards. As these compliance regulations changed, manufacturers started implementing solutions to satisfy these demands and maintain pharmaceutical compliance. While there are elements of each nation’s legislation that are universal, there are also distinctive elements.
A track-and-trace system is being implemented in the United Arab Emirates (UAE) by the Ministry of Health and Prevention (MoHAP) to secure products and ensure the safety of consumers. The system, called Tatmeen, is a completely automated, paperless system for managing drugs and medical supplies in the UAE healthcare industry. The rule is scheduled to go into effect for pharmaceutical companies doing business in the UAE market in January 2023.
Tatmeen is the IT regulatory system that will support the UAE T&T legislation for the pharmaceutical industry. A serialized unique identification must be visible on the secondary packaging of every product sold in the UAE. A serialized unique identifier must also be shown on aggregated packaging (or aggregated homogenous items or logistics units). The operational and transactional motions of the products across the supply chain and when dispensing to the patient/consumer must be tracked using the proper serialized identifiers.
The primary objectives of MoHAP with regard to the new laws in the UAE are to automate procedures, use GS1-compatible serialization, and increase the visibility, security, and dependability of the pharmaceutical supply chain. Both locally produced and imported goods must have 2D Matrix Barcodes for tracking, and businesses must be registered with Global Location Numbers (GLN). These mandatory regulations ensure Tatmeen has everything it needs to monitor production and increase visibility and safety within the UAE healthcare sector. Companies should start determining the steps they need to take to comply with MoHAP regulations.
ASL BELGISI is the name of the traceability system used in Uzbekistan. It is run by the equivalent of Russia’s Center for Research in Perspective Technologies (CRPT), CRPT Turon, which also runs Russia’s National Track and Trace Digital System (Chestny ZNAK). Many pharmaceutical compliance requirements for 2023 are connected to it, although some are independent.
Resolution No. 149, “On the Introduction of a System of Mandatory Digital Labeling of Medicines and Medical Devices,” was approved by the Cabinet of Ministers of Uzbekistan. According to rfxcel.com, this defined the subsequent labelling requirements for pharmaceuticals and medical equipment:
- September 1, 2022: products produced with secondary (external) packaging (except for orphan drugs)
- November 1, 2022: products produced with primary (internal) packaging (provided there is no secondary packaging) and medical agricultural products (except for orphan drugs)
- March 1, 2023: products and medical products to treat orphan diseases as designated by the Ministry of Health
- March 1, 2023: drugs included in the register of drugs with foreign registrations, the results of which are recognized in Uzbekistan
- February 1, 2025: medical products on a list approved by tax authorities and the Ministry of Health
Fortunately, there is a grace period for mandatory labelling in the following circumstance:
- Products were produced domestically within 90 days of these deadlines
- Products were imported within 180 days of the deadlines
Products must be labeled with a two-dimensional barcode according to GS1 Data Matrix Standards:
1. A 14-digit product code (i.e., Global Trade Item Number, or GTIN)
2. A 13-character randomized serial number generated by CRPT Turon or a supply chain participant
3. A four-character verification key generated by CRPT Turon
4. A 44-character verification code (i.e., crypto code) generated by CRPT Turon
The human-readable part must feature:
1. GS1 Global Trade Item Number (GTIN) (14 digit) – AI (01)
2. Expiration Date (YYMMDD format) – AI (17)
3. Serial Number (13 digits) – AI (21)
4. Batch or Lot Number – AI (10)
It is interesting to note that these regulations do not only have to do with pharmaceutical compliance, but also apply to five other product categories: tobacco; alcohol, including wine and wine products; beer and brewing products; appliances; and water and soft drinks.
The government of Kazakhstan released guidelines on labelling, marking, and procedures for accessing and uploading data to a single site in September 2015, which marked the start of the transformation of the country’s pharmaceutical compliance and supply chain practices. The Ministry of Health commissioned GS1 Kazakhstan to carry out a pilot for the traceability system, known as the Special Information System for Marking and Traceability of Goods, in November of that same year (IS MPT).
After the initial pilot run of this system and set of regulations, there are several upcoming deadlines:
- June 5, 2022: The Ministry of Health delays the first phase of serialization from May 2022 until August 1, 2022.
- August 2022: Mandatory serialization for the 93 products begins. This list includes drugs produced by four Kazakh manufacturers and 12 foreign manufacturers.
New proposed timelines by KZ Government not yet approved and signed:
- July 1, 2024: Mandatory serialization for 40% of drugs purchased by the Single Distributor is scheduled to begin
- January 1, 2025: Mandatory serialization for prescription drugs (approx 30%) is scheduled to begin
- July 1, 2025: Mandatory serialization for over-the-counter drugs (approx 30%) is scheduled to begin
- Starting from July 1st, 2024, complete traceability will be put into effect.
As in other EAEU and CIS countries, products must be labelled with a DataMatrix code with four data points:
- A 14-digit product code (i.e., Global Trade Item Number, or GTIN) (GS1 Application Identifier 01)
- A 13-character randomized serial number (21)
- A four-character verification key (91)
- A 44-character verification code (92)
2019 saw the release of Decree No. 470/12.09.2019 for “Product Marking identification in the Kyrgyz Republic” and Decree No. 554/17.10.2019 by the Kyrgyz Republic Government. The technique for digitally identifying products in the Kyrgyz Republic was then followed by a trial project. The track and trace standards for pharmaceuticals are outlined in Order No. 1110/09.20.2022 – Traceability system for medicines and medical device identification of the Kyrgyz Republic, which was released by the government in September of this year.
When it comes to the near future, there are four waves of serialization implementation, each with its own pharmaceutical compliance requirements. These waves are planned for January, April, and August of 2023. It is important to note, however, that these waves are related to voluntary serialization. Serialization will be compulsory starting in September 2023 for all items, in accordance with the EAEU’s mandate to notify the Eurasian Commission nine months prior to the implementation of serialization. Discretionary lists will be created by the Department of Medicines.
As far as barcode requirements go, they must include 2D DataMatrix code with GTIN, serial number (SN), and verification code (cryptotail). The human-readable part must also feature the batch number and expiration date.
It should be noted that the legal and official requirements are yet to be determined.
Pharmaceutical compliance requirements in Indonesia have some key differences compared to many other countries. Let us take a look at the key points regarding Indonesia’s serialisation and traceability regulations as outlined by optelgroup.com and see where these differences lie:
- All pharmaceutical manufacturers must pack their products with a 2D barcode to facilitate tracking and tracing
- The barcodes used must be in line with GS1 standards
- Pharmaceutical companies can generate the barcodes on their own, or obtain them from the Indonesian Food and Drug Authority, aka BPOM-Bedan Pengawas obat dan Makanan
- Two barcodes will be used for serialisation – Identification Barcode and Authentication Barcode
- By 2023, all eligible pharma products must be marked with an Identification Barcode
- By 2025, all eligible pharma products must be marked with an Authentication Barcode
As you can see, Indonesia’s traceability requirements stipulate the use of two barcodes: one for identification, and one for authentication. Products that do not need serialization should have identification barcodes applied, while those that do need it should have authentication barcodes applied. The Identification Barcode is a QR code that can be used on over-the-counter medications, prescription drugs, processed foods, cosmetics, and supplements. The barcode generated via electronic Marketing Authorization (MA) permission must be obtained by manufacturers.
The identification barcode contains the MA Number (NIE) or the registration number as well as their validity. The authentication barcode contains the MA Number or an internationally valid identity product number, a batch number or production code, a serial number, as well as an expiration date.
It should be noted that not all products require barcodes. Here is a list of exceptions:
- Blister packs, strip packs, pre-filled syringes, ampoules, and tubes less than 5 mg in weight
- Drugs having a volume of less than 5ml
- Stick packs, single packaging, suppositories, and catch covers
Serialization and the use of DataMatrix were optional for manufacturers and sponsors supplying medications in Australia until January 2023. The National Medicines Policy aims to meet the needs for medications and related services in order to achieve both the best possible health outcomes and economic goals. The Therapeutic Goods Order – Standard for labels of prescription and related medicines (TGO) No.91 and TGO No.92 documented the requirements that are consistent with this policy. TGO No. 106 was released in March 2021, harmonizing with international standards for pharmaceutical compliance and offering uniformity for sponsors and manufacturers who operate in numerous countries in order to guarantee universal compatibility.
The requirements are stated in the document clearly. According to sections 8, 9, and 10 of TGO 106, products subject to the rule for serialization are serialized, and these products included a DataMatrix code with an encoded GTIN (according to sections 9 and 10 of TGO 106). The TGO No. 106 starts on January 1st, 2023. The policy sets out four main objectives:
- timely access to the medicines that Australians need, at a cost individuals and the community can afford;
- medicines meeting appropriate standards of quality, safety and efficacy;
- quality use of medicines;
- maintaining a responsible and viable medicines industry.
The barcode requirements are: GTIN, Expiry date, Batch/Lot, Serial Number. There are some caveats to this, though. If a medicine container or single unit packaging within a container is serialized, the GTIN and Serial Number must be encoded in the data matrix code. Likewise, if a medicine is not serialised, there are no requirements for additional data to be included within the DataMatrix.
There are also exceptions:
- Export medicines
- Blood or blood product
- Medicines supplied under special circumstances
- Medicines imported for use by immediate family
Are you ready for the pharmaceutical compliance requirements of the future?
We hope that this article has offered you some valuable insights into what you need to be aware of going forward when it comes to compliance and serialization. While we could not cover every single country, we did try to go over those that are facing upcoming changes in their serialization and traceability practices. If your business is from any of these places, make sure to study these requirements even further to make sure you will not face any legal trouble or endanger innocent lives.
If you want any help meeting these requirements or any other assistance with serialization, we at Nubinno are here for you. Feel free to contact us with any queries you might have. Additionally, you can browse our blog for other informative articles on topics regarding pharma serialization.