Post by account_disabled on Mar 16, 2024 6:04:44 GMT
Packaging of medicines and supplements contains various designations, symbols and letter abbreviations that are not easily understood by consumers. These designations include the lot number on the packaging. In our article, we will explain how it should be interpreted and where the requirement to use this abbreviation on packaging and brochures comes from. Published: 08-08-2023 Abbreviations on medicine packaging: what do they indicate? Medical devices, medications and supplements constitute a specific group of products. They are subject to strictly defined legal rules, covering, for example, the scope and type of information provided on the packaging. What do the codes and abbreviations on drug labels or package inserts mean? They indicate, among others: the abbreviated name of the manufacturing company (for example: Polpharma as PPH) country of origin of the drug, the content of the medicinal substance in a specific unit of measurement, expiration date of the medicine, Lot Number, rules for using the drug or its reactivity with selected substances, information on the availability of the medicine: whether it is available to the general public or by prescription. Some medicines distributed in Poland may also have special labeling in the form of a QR ID code. In addition, many packaging manufacturers also use color markings that indicate the range of effects of medicinal substances. Consult the PCC Group's range of pharmaceutical raw materials and additives . The Lot designation in light of Polish law Obviously, the choice of designations on drug packaging is not random.
Pharmaceutical companies are required to comply with current guidelines on product labeling. Guidance on the use of Lot and other designations is included in, for example: Notice of the Minister of Health of on the announcement of the consolidated text of the Regulation of the Minister of Health on the requirements for the labeling of medicine containers and the contents of the leaflet, Pharmaceutical Law of of the European Parliament and of the Council, of 6 November 2001 , on the Community code relating to medicinal products for human use . The aforementioned Polish and EU laws concern the issue of the designation used on product packaging and brochures. One of those designations is Lot, what does it mean? Let's check. Lot: what CZ Leads does it mean when indicated on the package? The abbreviation: Lot is a common symbol that appears as a standard on the sides of the packaging of various medicines and on the contents of the leaflets. How should it be understood? The lot indicates the batch number of the medication. According to the Pharmaceutical Law, a batch should be understood as: a specific quantity of a medicine or pharmaceutical raw material or packaging material, produced in a process that consists of one or more operations in such a way that it can be considered homogeneous (Art. 1 inc. 37 of the Pharmaceutical Law). In accordance with EU regulations, the production of each batch of medicines is subject to specific guidelines: assigning a number to a particular batch means that it has passed the necessary checks and has been approved for marketing.
Optionally, Lot can also be replaced by the abbreviation "S", as long as the expiration date is marked Tw (which stands for EXP). On many packages of medicines, cosmetics and dietary supplements, you can also see that the abbreviation Batch is accompanied by a standard description, that is: batch number. In some countries outside the European Union, the batch number is known as: lot number. This information must be included on the box, container or leaflet. Lot vs EXP: what is the difference between the two abbreviations? As indicated by the legislator, the Lot as the designation of the batch number of the product must appear next to the designation EXP (in capital letters). What does EXP mean? On the packaging of medicines, indicate the expiration date of the product. As standard, next to the EXP symbol, there is information about the expiration year and month. According to Polish law, the expiration date of the medicine must be presented as follows: understandable, unencrypted, specifying the month and year: the month must be presented as 2 digits or at least 3 letters, and the year, as 4 digits. Thanks to readable and understandable EXP data, consumers, pharmacists and controllers can easily check whether a given product can be used freely, whether it is fresh and whether its properties are preserved. Why were designations like Lot introduced? The Polish pharmaceutical industry continues to develop and new medicines and supplements are still being launched on the market.