Marketing Authortitzations

True (A)

Magistral Preparations

<p>By the same agencies regulating human drugs, but with separate regulatory pathways (C)</p> Signup and view all the answers

<p>False (B)</p> Signup and view all the answers

<p>To minimize foreseeable risks associated with placing the medicine on the market.</p> Signup and view all the answers

<p>True (A)</p> Signup and view all the answers

<p>Biotechnology-prepared products for AIDS, cancer, or neurodegenerative diseases (B)</p> Signup and view all the answers

<p>False (B)</p> Signup and view all the answers

<p>To provide a cheaper alternative to a brand-name medicine (A)</p> Signup and view all the answers

<p>False (B)</p> Signup and view all the answers

<p>The Committee on Herbal Medicinal Products (HMPC)</p> Signup and view all the answers

<p>Well-established use and traditional use (C)</p> Signup and view all the answers

<p>False (B)</p> Signup and view all the answers

<p>Evidence of the suitability and validity of the indications for treatment and the safety of the product.</p> Signup and view all the answers

<p>The type of regulatory procedure used (A)</p> Signup and view all the answers

<p>False (B)</p> Signup and view all the answers

<p>A legal provision stating that a medicine's marketing authorization will cease to be valid if it's not placed on the market within three years of being granted or if it is removed from the market for three consecutive years.</p> Signup and view all the answers

<p>Using a medicine for unapproved indications or in a way not specified in the approved SmPC (D)</p> Signup and view all the answers

<p>True (A)</p> Signup and view all the answers

<p>To inform the patient about the benefits and risks of the off-label use, including potential consequences.</p> Signup and view all the answers

<p>To allow patients to access unauthorized medicines or authorized medicines from different countries (B)</p> Signup and view all the answers

<p>False (B)</p> Signup and view all the answers

<p>The medicine is expected to help patients with life-threatening, long-lasting, or seriously debilitating illnesses that cannot be treated satisfactorily with any currently authorized medicine.</p> Signup and view all the answers

<p>True (A)</p> Signup and view all the answers

<p>To monitor and detect any potential adverse effects or safety concerns related to the medicine (D)</p> Signup and view all the answers

<p>False (B)</p> Signup and view all the answers

<p>Commercial decisions or interruptions in the supply chain.</p> Signup and view all the answers

<p>False (B)</p> Signup and view all the answers

Any substance or combination of substances with therapeutic or preventive properties used to influence physiological functions through pharmacological, immunological, or metabolic effects.

Finished Pharmaceutical Products (FPPs) are manufactured by the pharmaceutical industry. They are the final form of a medicinal product, marketed under a specific name, and packaged in a specific way. FPPs are produced in batches.

A magistral preparation is a customized medication prepared by a pharmacist based on a specific patient's needs or prescription.

A batch refers to a quantity of medicinal products produced in one production cycle. The essential feature of a batch is its homogeneity.

Drugs intended for human use must undergo rigorous clinical trials and regulatory approval processes by agencies like the European Medicines Agency (EMA) or the U.S. Food and Drug Administration (FDA).

Veterinary drugs are regulated by agencies like the U.S. Food and Drug Administration's Center for Veterinary Medicine (CVM) or the European Medicines Agency (EMA) but with separate regulatory pathways.

Preclinical trials involve testing a new drug on non-human subjects, primarily animals, to evaluate its safety and potential efficacy.

Clinical trials are conducted on human volunteers to further assess the safety and efficacy of a new drug. These trials are conducted in phases and involve different participant groups.

The marketing authorisation process involves a comprehensive evaluation of a drug to ensure it is safe, effective, and of high quality before being placed on the market.

The dossier is a comprehensive document submitted by the manufacturer to the regulatory authorities, containing detailed information about a drug's development and characteristics.

The Summary of Product Characteristics (SmPC) is a document providing detailed information on a medicinal product for healthcare professionals.

The Patient Information Leaflet (PIL) is a document providing essential information about a medicinal product for patients.

The national procedure is a process for approving a medicinal product in a specific country. This procedure is less common nowadays.

The Mutual Recognition Procedure (MRP) involves a drug being approved in one EU member state and then recognized by other member states.

The Decentralised Procedure (DCP) is used for marketing authorisation of new drugs in multiple EU countries simultaneously.

The Centralized Procedure involves a centralised evaluation by the European Medicines Agency (EMA) for drugs that require specific safety and efficacy standards.

The Common Technical Document (CTD) is a standardized format for presenting documentation about a drug's development, harmonizing data requirements for global registration.

Biosimilars are biological medicines that are similar to an already approved medicine, meeting high standards for safety and efficacy. They are approved after patent protection of the original product expires.

The Committee on Herbal Medicinal Products (HMPC) evaluates herbal substances and preparations for safety and efficacy. It supports national authorities in approving herbal products.

Traditional herbal medicinal products are those that have been used traditionally for at least 30 years, with at least 15 years of use in the EU.

European Union monographs provide comprehensive scientific data for herbal substances and preparations, supporting the harmonisation of the European market.

The European Union list (formerly Community list) contains data on traditional herbal products, enabling national authorities to assess safety and traditional use without requiring additional data.

A homeopathic medicine is prepared from specific substances using a specific homeopathic manufacturing process as described in the European Pharmacopoeia.

The registration procedure for homeopathic medicines involves specific requirements based on the type of product and its intended use.

Named-patient basis access is the provision of unregistered or authorized medicines from another country for specific patients. It is usually used when other treatments are unavailable.

Compassionate use programs allow access to unregistered medicines for patients with serious conditions when no satisfactory authorized therapies exist.

Clinical evaluation of medicines involves testing a drug on patients through approved clinical trials, ensuring safety and efficacy before authorization.

Off-label use involves using a registered medicine in a manner not described in the approved Summary of Product Characteristics (SmPC).

The 'sunset clause' states that if a medicine is not placed on the market within three years after authorization or if it is removed from the market for three consecutive years, the authorization will lapse.

Parallel distribution is the distribution of a centrally authorized medicinal product from one Member State to another by a pharmaceutical company that is independent of the marketing-authorisation holder.

Parallel import involves importing a centrally authorized medicinal product from another EU country. The imported product must be identical and safe.