science

Marketing authorisation

Marketing authorisation is a science topic covered in the lgStudy science library. This page brings together a partial reference excerpt, illustrations, worked examples, real-world applications and a short study plan, so you can understand Marketing authorisation rather than just read about it. In short: 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. This process is performed within a legal framework defining the requirements necessary for successful application to the regulatory authority, details on the assessment procedure (based on quality, efficacy and safe…

Key takeaways

Marketing authorisation belongs to science; place it in that map before memorising details.
Learn the definition first, then one example that makes the definition concrete.
Connect Marketing authorisation to a quantity you can measure, compute or draw — that is where exam questions come from.
Reproduce the core statement of Marketing authorisation from memory before moving on to harder problems.

Reference excerpt

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. This process is performed within a legal framework defining the requirements necessary for successful application to the regulatory authority, details on the assessment procedure (based on quality, efficacy and safety criteria), and also the circumstances where a marketing authorisation already granted may be withdrawn, suspended or revoked. The application dossier for marketing authorisation is called a New Drug Application (NDA) in the USA or Marketing Authorisation Application (MAA) in the European Union and other countries, or simply registration dossier. This contains data proving that the drug has quality, efficacy and safety properties suitable for the intended use, additional administrative documents, samples of finished product or related substances and reagents necessary to perform analyses of finished product as described in that dossier. The content and format of the dossier must follow rules as defined by the regulator. For example, since 2003, the authorities in the United States, the European Union and Japan ask for the Common Technical Document (CTD) format, and more recently, its electronic version – the electronic Common Technical Document (eCTD). The application is filed with the regulator, which can be either an independent regulatory body or a specialised department in the ministry of health. Depending on jurisdiction, the resulting document may be more detailed (in addition to data identifying the product and its marketing authorisation holder), for example containing addresses of all manufacturing sites, appended labelling, artwork of packaging components, etc. or may be simplified to a one-page document called certificate of registration (and containing minimal data identifying the product and its source).

Procedures for obtaining a marketing authorisation Authorisation processes follow either a purely national procedure, with rules and requirements as per national legislation in force, as it occurs in most of countries worldwide, or should follow a centrally approval or a mutual recognition of decentralised procedures within the European Union.

Types of applications The type of application may vary according to status of the active ingredient. Thus, if the application concerns a new active ingredient (new active substance, new chemical entity, new molecular entity), one talks about a full application. Once a new active ingredient is authorised, any additional strengths, pharmaceutical forms, administration routes, presentations, as well as any variations (changes to the existing marketing authorisation) and extensions shall also be granted an authorisation or be included in the initial marketing authorisation, being subject of an abridged application. Special consideration is to be given to application for authorisation of biological products and biotechnology products, homeopathic products, herbal drugs, radionuclide generators, kits, radionuclide precursor radiopharmaceuticals and industrially prepared radiopharmaceuticals; in such instances, requirements are specific, in the meaning that they are special, more or less detailed, as per the nature of active ingredient.

Validity of marketing authorisations In most countries, a marketing authorisation is valid for a period of 5 years. After this period, one should apply for renewal of the marketing authorisation, usually by providing minimal data proving that quality, efficacy and safety characteristics are maintained and the risk-benefit ratio of the medicinal product is still favourable. However, in the European Union, after one renewal, the marketing authorisation shall remain valid for an unlimited period, unless the competent regulatory authority decides otherwise. If the marketing authorisation is not renewed in due time as requested by the local legislation, in order to maintain the pharmaceutical product on a market, one can apply for re-authorisation (re-registration). In such situations, the applicant may be requested to submit the whole items necessary for a full application. Marketing authorisation may be withdrawn, suspended, revoked or varied by regulatory authorities if under normal conditions of use the benefit over risk ratio is no more favourable, the product is harmful, or if it lacks therapeutic efficacy; also, one of the above actions can be taken if the qualitative and quantitative composition or other qualitative aspects (control) are not as currently declared. Marketing authorisation may be also withdrawn, suspended or revoked if the marketing authorisation holder or its representative does not fulfil other legal or regulatory obligations necessary to maintaining of product on the market, as per the legislation in force. Also, the marketing authorisation is withdrawn in the EU if the product is not placed on the market within next 3 consecutive years after granting of authorisation or if it is no more marketed for 3 consecutive years (so-called “sunset clause”).

Worked examples

Example 1 — a first encounter with Marketing authorisation

Start with the simplest possible case. Write down what Marketing authorisation claims or describes in one sentence, then invent the smallest concrete situation in which that sentence is true. In science, the smallest case is usually a single object, a single equation or a single measurement. Check that every symbol or term in your sentence has a meaning in that case.

Example 2 — changing one variable

Take the situation from Example 1 and change exactly one quantity: double it, halve it, or set it to zero. Predict what should happen to Marketing authorisation before you calculate. Comparing your prediction with the result is the fastest way to find out whether you understand the idea or only the words.

Example 3 — an exam-style question

Typical questions about Marketing authorisation ask you to (a) state it precisely, (b) apply it to given data, and (c) explain a limitation. Practise writing all three answers in under five minutes; the third part is what separates a full-mark answer from an average one.

Applications of Marketing authorisation

In research: Marketing authorisation appears in science research whenever the underlying quantities have to be modelled precisely. Papers usually cite it as a starting assumption and then explore where it breaks down.
In technology and industry: Engineering practice reuses Marketing authorisation in design rules, simulations and safety margins. Knowing the idea lets you read a specification sheet and understand why the numbers look the way they do.
In the classroom: Marketing authorisation is common in secondary-school and first-year university syllabi. It links to neighbouring topics Drug development, Pharmaceuticals policy, so understanding it makes those chapters shorter.
In everyday life: Look for Marketing authorisation outside the textbook — in sport, cooking, traffic, electronics or the sky above you. An example you found yourself is remembered far longer than one you were given.

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How to study Marketing authorisation in 20 minutes

Read the reference excerpt below once, without taking notes.
Close the page and write down what Marketing authorisation means in your own words.
Compare your version with the excerpt and mark what you missed.
Work through the three examples above with pen and paper.
Explain Marketing authorisation out loud to somebody else — or to Teacher Smith in the lgStudy chat.

Frequently asked questions

What is Marketing authorisation in simple terms?

Why does Marketing authorisation matter?

Because it connects several science ideas at once: it gives you a definition you can apply, a quantity you can calculate, and a way to check whether a result is plausible.

How should I study Marketing authorisation?

Read the excerpt, restate it from memory, then work through the examples and applications listed on this page. The five-step study plan above takes about twenty minutes.

What does this page cover?

It gives you a compact reference excerpt plus original lgStudy explanations, examples, applications and study material on Marketing authorisation.