International nonproprietary name of drugs. Medicines - Pavlova I.I.

The life of any medicine begins with a name, of which there may be several - chemical, trade, national generic, generic or international generic name medicine (abbreviated as INN). The latter is considered particularly important for all medical and pharmaceutical workers. This name is assigned to the active substance of the drug, has worldwide recognition and is considered public property.

Some historical facts about INN

The system of international nonproprietary names was initiated by a resolution of the World Health Assembly in 1950. The first list of INNs was published three years later.

From this period the system started working. Currently, this organization constantly publishes a directory of international nonproprietary names of medicines and a journal containing a list of INNs. The essence of the system is to help healthcare professionals, using an exclusive and at the same time common name throughout the world, identify each pharmaceutical substance. An international range of such substances in INN form is necessary for:

• international information exchange between medical and pharmaceutical workers, as well as scientists;
• safe prescribing and dispensing to patients;
• identification of drugs.

Objectives of the INN system

The international nonproprietary name of a medicine is unique and should not be similar to other names so that it cannot be confused with other widely used names. In order for these names to be used throughout the world, they are non-proprietary, meaning they can be used without restrictions to identify pharmaceutical substances. One of the features of the INN system is that due to the use common elements words in the names of substances that are similar in pharmacological properties, their relationship can be traced.

As a result, any specialist in the field of pharmacy or medicine understands the belonging of substances to certain group, having similar activity.

Using INN

INNs belonging to the same pharmacological group have similar properties. names of medicines are used:

• when labeling;
• in advertising publications;
• V scientific literature;
• V regulatory documents;
• in information about the medicine;
• in pharmacopoeias.

Their use is provided for by international or national legislation. To avoid confusion and to ensure that there is no threat to the health of individuals, it is prohibited to borrow trade names from the INN. There are countries that have a specific font size that allow a generic name to be printed under an advertisement or brand marking.

Why is INN assigned?

International nonproprietary names of medicines are assigned in accordance with a certain procedure by a specially created commission World Organization health (WHO). A generic name helps specialists understand the variety of medications that appear on the pharmaceutical market after the patent for the original drug expires. Many drugs with the same INN have different trade names. For example, a medicine called “Ciprofloxacin” - this INN has about thirty-eight trade names, “Diclofenac” - fifty-two, and the well-known “Paracetamol” - thirty-three. Many drugs are produced based on one substance, for example:

• 55 drugs are created from penicillin;
• from nitroglycerin - 25;
• from diclofenac - 205.

Every year total The INN is increasing by more than one hundred items. Currently there are more than eight and a half thousand of them.

How is the list of international nonproprietary names of medicinal products selected and published?

INN is assigned only to those substances that can be characterized by a chemical formula or nomenclature. In accordance with the policy followed by WHO, names are not selected for herbal and homeopathic preparations, as well as mixtures. In addition, names are not selected for substances that are used for a long period of time. medical purposes under specific names and for some common chemical names, e.g. acetic acid. The selection process itself is quite lengthy, lasting more than two years. After notifying the submitter, WHO publishes all names in a special journal. During the year, starting in 1997, the following lists of titles are issued:

• proposed;
• recommended.

Moreover, they are compiled in Spanish, English, French, and also contain Latin name each INN. In addition, it is printed full list international nonproprietary names of medicines. It is subject to regular updating. It lists the names on six different languages, including in Latin.

Application of INN

The growth in the number of non-proprietary names is also expanding the scope of their application. Thanks to the global recognition and active use of the INN system in practical medicine Most pharmaceutical substances are designated using an international nonproprietary name. When completing clinical documents or conducting various studies INN is used quite widely and has become quite commonplace. In addition, the importance of INN is increasingly increasing as a result of active use for pharmaceutical products generic names.

Use of INN in practical medicine

What is international generic name medicines? IN Federal law“On the circulation of medicines” this concept is deciphered in the following way is the name of the pharmaceutical substance proposed by WHO. As mentioned above, the INN system was invented to classify and record the names of active substances and their free use in the medical and pharmaceutical community. Since 2012, in practical medicine, all prescriptions and prescriptions of medications are carried out using INNs, and in their absence, using group names. When selecting a drug, doctors need to distinguish between the following concepts:

• name of the active substance;
• trade name of a medicine containing a pharmacologically active, i.e., active substance.

There are a huge number of trade names drugs that are manufactured by different manufacturers, but have the same active ingredient. In all official instructions By medical use medications, and the packaging also contains the international nonproprietary name of the drug. Knowledge and use of INN allows doctors to effectively and efficiently prescribe medications, as well as economically use limited financial resources.

Search for analogues and synonyms

Analogues are medicines that have similar pharmacological effect and mechanism of action. Such drugs may belong to different pharmacological groups, have different therapeutic effect, have different contraindications and side effects. For example, "Remantadine", "Kagocel", "Ingavirin" are similar means. Synonyms are drugs with different trade names, but having the same INN. Let's look at a few examples of synonymous drugs. Listed below are medications with the international nonproprietary names “Drotaverine” and “Paracetamol”.

The first includes “No-shpa”, “Spazmol”, “Spakovin”, “Spazmoverin”, the second - “Kalpol”, “Ifimol”, “Prohodol”. Many people confuse these two concepts and often look for cheap analogues in pharmacies. It is important to understand that the analogues are not synonymous, and only a doctor can choose them correctly. And any patient can choose a synonym drug independently, depending on the preferences of a particular trade name and the country of origin of the drug.

Dear customers!

For your convenience, we have expanded the search options medicines available in the pharmacy chain.

There are now two search options available on the site:

By International Nonproprietary Name - INN;
- by the generally accepted trade name of the drug.

To search, you just need to specify a few alphabetic characters (at least 3), which is convenient if, for example, you are not sure how to correctly spell a particular drug name.

We remind you that the INN is the unique name of the active substance or active ingredients, recommended by the World Health Organization (WHO). Thanks to INN, doctors and pharmacists have the opportunity to navigate the huge and constantly changing range of the pharmaceutical market, and medical institutions- do necessary purchases medications.

The same INN may have medicines with different trade names given to them by pharmaceutical manufacturing companies, and often sold in a different dosage form.

For example, by entering the word "in the search bar on the website" diclofenac" (one of the common INNs), we get an extensive list of drugs. In Russia alone, today about 170 drugs containing this are registered active substance with antirheumatic effect:

Another example is the search for drugs based on sterile isotonic sea water for rinsing and cleansing the nasal cavities and restoring free nasal breathing:

INN	TRADE NAMES OF DRUGS
SEA WATER (AQUA MARINA)	AQUA MARIS AQUALOR MARIMER KVIX OTRIVIN SEA HUMER PHYSIOMER

What should you pay attention to regarding INN?

1. The INN is always indicated on the packaging of the medicine: just below its trade name and in smaller font (in Russian or Latin).

2. INN is also indicated in reference publications about medicinal products.

* The list of INNs for pharmaceutical substances already includes more than 8,000 names, and WHO registers 120-150 new ones every year.
** Not the entire list of names registered by WHO can be found in Russian information resources.

3. Searching for medicines using INN is convenient and justified if you need to purchase high-quality generic drugs that have one active ingredient (INN), but are sold in pharmacies under different names trademarks.

4. Please note that original drugs and generic drugs are NOT NECESSARILY bio- or therapeutically equivalent!

What should you pay attention to regarding the trade name of the drug?

1. Trade names are often referred to as proprietary and commercial names. The bottom line is that manufacturing companies try to assign brand names to their products, which allows them to market and advertise drugs specifically to consumers. own production.

2. Trade names are most often mentioned in advertising and are always present on the packaging of drugs (indicated in large print!).

3. Trade names of many drugs are brands. Brand names are given to all original drugs, the right to produce which for a certain period belongs exclusively to the developer company (a patent for monopoly production is given for 5 years).

Subsequently, other pharmaceutical companies receive the right to use the same INNs in production own drugs with other trade names - that is, generics. The production of generics is noticeably cheaper (there are no development costs). And consumers, accordingly, benefit by more affordable prices.

Additional information O

Each medicine can have 3 names:

· Complete chemical name– description of the structure of the molecule according to the international chemical nomenclature;

· Nonproprietary name, international nonproprietary name (INN, INN) – a name that is issued to a medicinal product by a special WHO committee or a national pharmacopoeial committee. This name is not anyone's intellectual property and can be used by any drug manufacturer. When choosing an INN, 3 principles should be taken into account:

· The name must have a distinct sound and spelling;

· The name should not be similar to existing drug names;

· The name must reflect the generic relationship of the medicines. For example, the suffix -olol for b-adrenergic receptor blockers, -pril for ACE inhibitors, -sartan for angiotensin AT1 receptor antagonists, prefixcefa- for cephalosporin antibiotics.

· Patented (brand) names are a trademark that is assigned to a specific drug by the manufacturer. Without the permission of the rights owner, no company can produce a medicine under this brand. The patented name is an a priori guarantee of a certain level of quality of the drug. Proprietary names are not subject to the same requirements as INNs. Typically, a proprietary name includes part of the name of the manufacturer. For example, mebendazole from Pharmacar is called Vermacar®.

In principle, it is believed that if a doctor prescribes a medicine under its brand name, he wants that particular medicine to be given to the patient. If the pharmacist for any reason cannot do this and dispenses a medicine produced by another manufacturer, he is not only obliged to inform the patient about this, but also explain to him that he must contact the doctor and clarify how the replacement will affect the treatment plan.
If a doctor prescribes a medicine under his INN, then he leaves the right to choose the manufacturer of the medicine to the pharmacist and leaves at his discretion the possibility of the so-called. generic substitution (i.e. dispensing a drug under any of its trade names).
Depending on the manufacturer, branded and generic medicines are distinguished:

· Brands ( original medicines) – drugs that are produced by the developer, i.e. pharmaceutical concern that discovered this medicine and carried out all stages of its study. All branded drugs, after their discovery, are under patent protection (the patent period in most countries is 15 years). The production of new drugs is a very expensive process; according to 1994 data in the United States, the cost of developing a new drug ranged from 200 to 300 million dollars. According to a report published by the largest French corporation Servier in 2002, in 30 years it managed to register only 30 new drugs (the corporation's research department employs 2,400 people).

· Generics (generic drugs) - produced by a pharmaceutical concern under a license from the owner company or after the patent for the drug has expired. Generics are not required full program studies, in order to register them, the company sometimes only needs to provide data on the absorption of the drug in comparison with the brand-name drug. Thus, generic drugs are always cheaper than their branded counterparts, because the company does not spend money on 10-15 years of drug research, but uses ready-made data. Currently, a large pharmaceutical company is capable of launching an average of 30 new generic drugs per year.

To summarize the above, it should be noted that any medicine can be presented on the market in 3 versions:

· Branded drug having trade name. For 15 years after the discovery of the drug, it was the only one on the market.

· Generic drug under a trade (brand) name;

· Generic drug under INN.

A study carried out in Great Britain in the 90s of the 20th century showed that about 41% of prescriptions prescribed by doctors contained INN drugs.

The costs of creating drugs are so high that the famous Bayer concern, which created aspirin ( acetylsalicylic acid) still can't cover primary expenses(adjusted for inflation) associated with the development of this medicine.

Rules for dispensing medications from pharmacies

Medicines can be dispensed from pharmacies both with a prescription and without a prescription. The list of medicines approved for sale without a prescription has been approved by the USSR Ministry of Health. All other medicines are dispensed from pharmacies only according to prescribed prescription forms.

Recipe (from the Latin word “gearege” - to take or gesertum - taken)- a written instruction from a medical professional to a pharmacy regarding the preparation and dispensing of a medicine, indicating the method of its use.
Doctors working in medical institutions and research institutes and treating outpatients, as well as hospital doctors, as an exception, have the right to write prescriptions only when a patient is discharged if it is necessary to continue the course of treatment that has been started.
The right to prescribe a prescription is also granted to authorized medical workers(paramedics, obstetricians) who are allowed to independently issue a prescription in accordance with the established procedure.
General rules the writing of prescriptions and the dispensing of drugs according to them are approved by the Ministry of Health of the USSR. It is not allowed to issue prescriptions to patients who are on inpatient treatment, as well as for drugs not included in the USSR medicinal drug register.
The prescription must be written out indicating the position and title of the person giving the prescription, with his signature and personal seal, as well as taking into account the age of the patient, the procedure for paying for the medicines and the effect of the incoming ingredients.
Prescriptions are written clearly and legibly in ink or ballpoint pen on approved and printed forms. Corrections to recipes are not allowed.

A prescription is a written request from a doctor or other authorized person (dental technician, paramedic, midwife) to a pharmacist about the preparation and dispensing of a medicinal product to a patient, indicating how this medicinal product should be used.

· The recipe is legal document and is carried out in accordance with the rules established by Order of the Ministry of Health of the Russian Federation No. 328 of August 23, 1999 “On the rational prescription of drugs, the rules for writing prescriptions for them and the procedure for their dispensing by pharmacies.”

Prescriptions must be written on forms measuring 105*148 mm, printed using forms approved by the Ministry of Health of the Russian Federation, indicating the full name, age of the patient, the procedure for paying for the medicine, as well as the ingredients included in the medicine. When specifying the payment procedure, what is necessary is underlined, what is unnecessary is crossed out. The order of the Ministry of Health of the Russian Federation approves 3 forms of prescription forms: No. 148-1/u-88, No. 107-u and a special prescription form for NLS.

Prescription forms of form No. 148-1/u-88 are intended for prescribing and dispensing drugs:

· included in the list of substances of list III (list III is the “List of NS, substances and their precursors subject to control in the Russian Federation”);

· potent and toxic substances(these substances are approved by the Standing Committee on Drug Control), drugs: apomorphine hydrochloride, atropine sulfate, homatropine hydrobromide, dicaine, silver nitrate, pachycarpine hydroiodide, anabolic steroids, as well as sold free of charge and with a 50% discount.

All other drugs, including lists A and B, as well as those containing ethanol written out on form No. 107-u.

Medicines are divided into official And main:

* Official(from Latin officina - pharmacy) are medicines produced by industry, having a standard composition given in pharmacopoeial monographs. They are approved for use by the Ministry of Health. For example, cephalexin tablets, Lorinden ointment. Such funds can be issued under trade or international non-proprietary names.

* Mainline (extemporaneous) (from lat. magister – teacher, ex tempore – as needed) refer to medications formulated at the discretion of the physician. They are prepared in a pharmacy according to a prescription for a specific consumer.

Accordingly, they distinguish official and main prescriptions of medicines:

· Official copybooks– prescriptions of finished medicinal products approved by the Ministry of Health of the Republic of Belarus, recommended for medical use.

· Main (extemporaneous) prescriptions are compiled at the discretion of the doctor.

Exist abbreviated, expanded and semi-abbreviated forms of recipes.

1. B abbreviated form at the beginning of the copybook indicate dosage form , then the name of the drug, its concentration and dose. As a rule, official drugs are prescribed in an abbreviated form. Commercial names of medicines with complex composition are usually written out in the same form.

Titles official medicines in the abbreviated form after the names of dosage forms are placed in genitive case singular. For example:

Recipe: Solutiōnis Gentamycini sulfātis 4% – 2 ml

Da tales doses numĕro 10 in ampūllis

Signa: 2 ml intramuscularly

Commercial names of drugs with complex composition in the abbreviated copybook, after the names of the dosage forms, they are written in quotation marks and placed in the nominative singular case. For example:

Recipe: Tabulettas "Quamatel" number 28

Yes. Signa: 1 tablet 2 times a day

2. B expanded form at the beginning of the prescription, the names of the ingredients included in the medicinal product are listed, then the dosage form is indicated. For example:

Recipe: Extracti Belladonnae 0.015

Olei Cacao quantum satis, ut fiat suppositorium rectale

Yes. Signa: 1 suppository per night into the rectum

3. Semi-short form used to prescribe medications that can be presented as a mixture of several dosage forms. This example is a mixture of solution and powders:

Recipe: Solutionis Procaini 1%-100 ml

Ephedrini hydrochloride 3.0

Diphenhydramini 1.0

Acĭdi ascorbinĭci 2.0

Misce. Yes. Signa: 10 ml per inhalation 1 time per day

This form is more compact and convenient than the unfolded one. It is used most often when prescribing medicines. Components can be registered under both international and trade names.

Doses of drugs in R. are indicated in the decimal measurement system. The unit of mass is 1 g. When dosing drugs, smaller values ​​are also used, for example 0.01 g - one centigram; 0.001 g - one milligram. Hard (tablets, powders, dragees) and soft (ointments, pastes and suppositories) dosage forms are dosed in grams. Quantity liquid substances(solutions, infusions, decoctions, tinctures, etc.) are indicated in milliliters, grams or drops. To prescribe a medicine in drops, guttas (drops) are written after its name and their quantity is indicated in Roman numerals. Usually the word guttas is abbreviated, for example, to indicate 5 drops, it is enough to write gtts V. When prescribing medications dosed in units of action (AU), the number of units is indicated in the prescription instead of weight or volume (for example, 40 units).

Sometimes the amount of constitiens is not given in R. (for example, in suppositories), giving the pharmacist the right to take it himself required amount; in this case they write quantum satis (as much as required). However, this applies only to indifferent substances.

Quantity medicinal substances, included in the recipe, indicate right side prescription form next to the name of the drug (or one line below). In cases where maximum dose poisonous or potent substances are deliberately exceeded, it is necessary to clarify their quantity in words, put an exclamation mark and a signature to confirm that this dose was not prescribed by chance. If the correctness of the prescribed dose is not confirmed, the pharmacist reduces the dose of the substance to 50% of the highest single dose specified in the pharmacopoeia.

Year of manufacture: 2012

Genre: Pharmacology

Format: DOC

Quality: TXT

Description: Quite often in a pharmacy you can hear from the pharmacist: “This medicine is not available. Take such and such, it’s a synonym.” What to do? After all, the doctor prescribed a drug with a different name! Let's look at medications and their names from a pharmacological point of view.
The drug naming system (nomenclature) is quite complex. Each drug has a chemical name, an international nonproprietary name (INN) and a trade name.
The chemical name is chemical formula active substance of the drug, that is chemical compound, which has therapeutic effect on the body. So, for example, the chemical name of potassium permanganate, which is familiar to everyone, is potassium permanganate, analgin is metamizole sodium, etc. Remembering the chemical name of the drug is not easy, and it is not necessary.
The “identifying” name for physicians around the world is the international nonproprietary name (INN) - this is the unique “name” of the active substance of the drug, which it receives during registration and which is approved by the World Health Organization (WHO). No matter what trade name the manufacturer produces the medicine under, it always indicates this, the same name for all. WHO regularly publishes and updates full list INN, in which INN names are indicated in Latin, English, French, Spanish, Arabic, Chinese and Russian. INN is not assigned to mixtures of several active substances (in this case the drug is called combined), herbal and homeopathic medicines, as well as substances that have long been used in medicine under stable names.
Trade name is the name of the medicine that the doctor prescribes to us and which we ask in pharmacies. This is a trademark of the manufacturer, protected by patent law. Trade names of drugs can be anything, but for the convenience of the consumer they should be as short, simple and easy to remember as possible. Although the trade name inherently does not reflect either chemical or pharmacological properties drug, sometimes the name contains an indication for use of this medicine: Dlyanos - a drug for the treatment of rhinitis (INN - xylometazoline), Diabeton - a drug for the treatment diabetes mellitus(INN – gliclazide), etc.
The company developing a new drug (chemical substance used for medical purposes) receives a patent - exclusive rights to production this drug within a certain period. Most of this time is spent on clinical trials drug (checking its effectiveness and safety). After which the company begins to sell its drug. This drug is called original.
Once the patent expires, other pharmaceutical companies acquire the right to sell a licensed version of the drug under their own brand names. These licensed drugs are called synonyms. They may differ from the original drug in inactive components ( excipients), size, color, shape and even dosage forms. And, of course, trade names. At the same time, differences in the effectiveness and safety of the use of synonymous drugs should not exceed 20%.
In this directory, medicines are presented in alphabetical order by international nonproprietary names or, in the absence of INN, by names of active substances ( combination drugs). For ease of use, the guide is provided alphabetical index medicines.

The names of medicines are presented in three versions: chemical, international nonproprietary and commercial.

Chemical name- reflecting the composition and structure of the medicinal substance. Chemical names are rarely used in practical healthcare, but are often given in annotations for medications and contained in special reference publications, for example: 1,3-dimethylxanthine, 5-ethyl-5-phenylbarbituric acid, etc.

International nonproprietary name (INN, International Nonpro-prietary Name, INN) - This is the name of the drug substance recommended by the World Health Organization (WHO), adopted for use throughout the world in educational and scientific literature for the purpose of convenient identification of the drug by belonging to a specific pharmacological group and in order to avoid bias and errors. A synonym for INN is the term generic or generic name. Sometimes the INN reflects the chemical structure of the drug, for example: acetylsalicylic acid, acetaminophen.

Trade name of the drug- name of the medicinal product assigned by its developer;

Patented commercial name (Brand name) - o but is assigned by pharmaceutical companies producing this particular original drug and is their commercial property (trademark), protected by a patent. For example, the trade name of acetylsalicylic acid is aspirin, furosemide is Lasix, and diclofenac is Voltaren. Trade names are used by manufacturing companies for marketing purposes, to promote and compete drugs on the market.

The concept of bioequivalence of drugs

An important concept is bioavailability, which is understood as “the speed and extent to which the active substance or its active ingredient is absorbed (absorbed) from the dosage form and becomes available at the site of action (systemic circulation)." Considering that when intravenous administration the drug almost completely enters the systemic circulation, it can be considered that its bioavailability absolute.

The drug whose bioavailability is being studied is test takers. As a rule, the drug being tested is a generic. It is compared to bioavailability reference drug (original or innovative).

Bioavailability is a key concept for understanding bioequivalence. If, after administration of the same molar concentration of the reference and test medicinal products, their bioavailability is similar to the extent that guarantees the same therapeutic effect and toxic effect, then we can assume that such drugs bioequivalent.

Also distinguished pharmaceutical equivalence, by which we mean that the tested drug contains an equal amount of active substance (substances) with the reference one, the same dosage form and meets comparable standards (production and quality). It is clear from the definition that if a company produces a dosage form with other excipients that significantly change bioavailability, then such a drug will be pharmaceutically equivalent to the original one, but not bioequivalent. A similar situation can occur if the manufacturer uses components that slow down absorption to create prolonged forms. Therefore, despite the same dosage form, they will have completely different pharmacokinetic curves in the blood serum.

A generic drug must exhibit a therapeutic effect equivalent to the original one. If, in clinical trials, drugs exhibit a comparable therapeutic effect, then such drugs are considered therapeutically equivalent. It is generally accepted that the therapeutic effect depends on the concentration of the active substance in the blood plasma. Based on this principle, drugs that have the same pharmacokinetic curve will exhibit comparable therapeutic effects.

A bioequivalence study is a clinical study and must comply with GCP requirements. This is one of the guarantees of the quality and evidence of the research.

During the study, individual pharmacokinetic parameters of the substance are determined for each subject (area under the curve, C max - maximum concentration, time to reach maximum concentration, etc.). The methodology and principles for calculating these parameters are widely covered in the scientific literature.

Proper clinical practice(Good Clinical Practice, GCP)- a standard of clinical research, covering the planning, conduct, completion, verification, analysis of results, reporting and documentation, which ensures the scientific significance of the research, its ethical acceptability and full documentation of the clinical characteristics of the drug being studied. As has been repeatedly noted in domestic and foreign literature, as well as in WHO documents, the consumer properties of drugs - effectiveness, safety and pharmaceutical aspects of quality - are ensured through compliance with the most important industry rules, in other words, GLP, GCP and GMP standards or codes during their development , testing and production.

GLP (GoodLaboratoryPractice, Good Laboratory Practice)- a system of norms, rules and guidelines aimed at ensuring consistency and reliability of laboratory research results. The system has been an approved national standard of the Russian Federation since March 1, 2010 - GOST R-53434-2009. The main goal of GLP is to ensure that the entire progress of a study can be fully traced and reconstructed. Quality control is called upon to be carried out by special bodies that periodically inspect laboratories for compliance with GLP standards. GLP sets very strict requirements for the maintenance and storage of records - significantly more stringent than the European standards of the EN 45000 series. The scope of application of GLP standards is established by law. First of all, this applies to the development of new chemical substances, receipt and use toxic substances and to healthcare.

GMP(“Good Manufacturing Practice”, Good Manufacturing Practice)- a system of norms, rules and guidelines regarding the production of: medicines, medical devices, diagnostic products, food products, food additives, active ingredients

In contrast to the quality control procedure by examining random samples of such products, which ensures the suitability of only those samples themselves (and, possibly, batches manufactured closest to the given batch), GMP standard reflects a holistic approach and regulates and evaluates the actual production and laboratory testing parameters.

To standardize the quality of medical care for the population, it is used together with the standards: GLP (Good Laboratory Practice), GCP (Good Clinical Practice, GDP (Good Distribution Practice).

Pharmacovigilance- a type of continuous monitoring of adverse events and others related to the safety aspects of medicines that are already on the market. In practice, pharmacovigilance relies solely on spontaneous reporting systems that allow healthcare professionals and others to report adverse drug reactions to a central unit. Said central unit then combines reports from multiple sources to create a drug safety information profile based on one or more reports from one or more healthcare professionals.

Toxicity – the property of a substance, when it enters the human body in certain quantities in animals or plants, to cause their poisoning or death.

Embryotoxicity – the ability of a medicinal substance to have a toxic effect on developing embryos; embryotoxicity can manifest itself in three main forms: embryo-lethal effect, teratogenic effect, general developmental delay.

Embryoletal effect– increase general level embryonic mortality, both preimplantation and postimplantation.

Teratogenic effect– anatomical, histological, cytological, biochemical, neurophysiological and other abnormalities that appear before or after birth.

Generaldelaydevelopment– changes in body weight, craniocaudal size, delayed ossification of skeletal bones.

Carcinogenicity b – the effect of a substance that can cause the development of tumors.

Mutagenicity - the action of a substance that can cause changes in the genetic apparatus of a cell and leading to changes in hereditary properties.