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| Acronym | PL code |
|---|---|
| Organization | |
| Example | PL 34985/0004 |
| Website | products |
A Product Licence Number (or PL code for short) is a unique identifier on the packaging of medicines, used to uniquely identify the product. This code will normally remain the same despite the varying marketing and branding of the companies selling it. [1]
The code itself is issued by the Medicines and Healthcare products Regulatory Agency [2] in the UK and the European Medicines Agency. [3]
Sales are activities related to selling or the number of goods sold in a given targeted time period. The delivery of a service for a cost is also considered a sale. A period during which goods are sold for a reduced price may also be referred to as a "sale".
In marketing, a product is an object, or system, or service made available for consumer use as of the consumer demand; it is anything that can be offered to a domestic or an international market to satisfy the desire or need of a customer. In retailing, products are often referred to as merchandise, and in manufacturing, products are bought as raw materials and then sold as finished goods. A service is also regarded as a type of product.
The International Standard Recording Code (ISRC) is an international standard code for uniquely identifying sound recordings and music video recordings. The code was developed by the recording industry in conjunction with the ISO technical committee 46, subcommittee 9, which codified the standard as ISO 3901 in 1986, and updated it in 2001.
Pharmacovigilance, also known as drug safety, is the pharmaceutical science relating to the "collection, detection, assessment, monitoring, and prevention" of adverse effects with pharmaceutical products. The etymological roots for the word "pharmacovigilance" are: pharmakon and vigilare. As such, pharmacovigilance heavily focuses on adverse drug reactions (ADR), which are defined as any response to a drug which is noxious and unintended, including lack of efficacy. Medication errors such as overdose, and misuse and abuse of a drug as well as drug exposure during pregnancy and breastfeeding, are also of interest, even without an adverse event, because they may result in an adverse drug reaction.
The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency (EMEA).
The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably safe.
GS1 is a not-for-profit, international organization developing and maintaining its own standards for barcodes and the corresponding issue company prefixes. The best known of these standards is the barcode, a symbol printed on products that can be scanned electronically.
A package insert is a document included in the package of a medication that provides information about that drug and its use. For prescription medications, the insert is technical, providing information for medical professionals about how to prescribe the drug. Package inserts for prescription drugs often include a separate document called a "patient package insert" with information written in plain language intended for the end-user—the person who will take the drug or give the drug to another person, such as a minor. Inserts for over-the-counter medications are also written plainly.
The European Directive on Traditional Herbal Medicinal Products (THMPD), formally the Directive 2004/24/EC amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use, was established by the European Parliament and Council on 31 March 2004 to provide a simplified regulatory approval process for traditional herbal medicines in the European Union (EU). Previously, there was no formal EU wide authorisation procedure, so each EU member state regulated these types of products at the national level.
The Commission on Human Medicines (CHM) is a committee of the UK's Medicines and Healthcare products Regulatory Agency. It was formed in October 2005, and assumed the responsibilities of the Medicines Commission and the Committee on Safety of Medicines. Membership in this various and extensive body is listed on a governmental website.
Marketing Authorisation Application (MAA) is an application submitted by a drug manufacturer seeking marketing authorisation, that is permission to bring a medicinal product to the market.
Global Medical Device Nomenclature (GMDN) is a system of internationally agreed generic descriptors used to identify all medical device products. This nomenclature is a naming system for products which include those used for the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans.
Marketing authorisation is the process of reviewing and assessing the evidence to support a medicinal product, such as a drug, in relation to its marketing, finalised by granting of a licence to be sold.
The Unique Ingredient Identifier (UNII) is an alphanumeric identifier linked to a substance's molecular structure or descriptive information and is generated by the Global Substance Registration System (GSRS) of the Food and Drug Administration (FDA). It classifies substances as chemical, protein, nucleic acid, polymer, structurally diverse, or mixture according to the standards outlined by the International Organization for Standardization in ISO 11238 and ISO DTS 19844. UNIIs are non-proprietary, unique, unambiguous, and free to generate and use. A UNII can be generated for substances at any level of complexity, being broad enough to include "any substance, from an atom to an organism."
Radiocentre is the industry body for commercial radio in the UK. It exists to maintain and build a strong and successful commercial radio industry. The organisation works on behalf of over 40 stakeholders who operate over 300 licensed radio stations across the UK and represent 90% of commercial radio in terms of listening and revenue.
ECHO-7 is a wild type member of the echovirus group of viruses. It was formerly approved as a virotherapy medication by the State Agency of Medicines of the Republic of Latvia (2004–19). In March 2019, the distribution in Latvia was stopped by the State Agency of Medicines, after laboratory tests found that the amount of ECHO-7 virus was in much smaller amounts than claimed. On May 31, 2019, the State Agency of Medicines suspended the registration licence of ECHO-7.
Afoxolaner (INN) is an insecticide and acaricide that belongs to the isoxazoline chemical compound group.
The distribution of medications has special drug safety and security considerations. Some drugs require cold chain management in their distribution.
The Falsified Medicines Directive is a legal framework introduced by the European Commission, to improve the protection of public health within the European Union. The directive applies since 2 January 2013. The European Commission Delegated Regulation, (EU) 2016/161, supplements Directive 2001/83/EC with rules regarding safety features for the packaging of medicinal products for human use. The regulation was adopted in October 2015. Measures to counteract to fake medicines include stricter record-keeping of wholesale distributors, tougher inspections of pharmaceutical producers, an EU-wide quality mark to identify online pharmacies and obligatory safety features on packages.
Valneva COVID-19 vaccine is a COVID-19 vaccine developed by French biotechnology company Valneva SE in collaboration with the American biopharmaceutical company Dynavax Technologies.
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