2.2.2
Active
Ingredients Controlled Vocabulary
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Scope: |
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The Active Ingredients Controlled Vocabulary includes active
ingredient terms related to approved medicinal products.
Excluded are active ingredients related to homeopathic
medicinal products and investigational medicinal products. |
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Definitions: |
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An active ingredient is defined as a substance
that alone or in combination with one or more other ingredients
produces the intended activity of a medicinal product.
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A substance is any matter and can be of human, animal, vegetable or chemical (natural, semi-synthetic or synthetic) origin. |
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An active moiety is the portion of the
active ingredient that is responsible for the effect.
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Methodology: |
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A comprehensive list of active ingredient terms has been collected based on the standard terminologies currently used by the EMEA, FDA, MHLW and Health Canada. The active ingredient terms are limited to English language terms, with the exception of herbal active ingredients, for which the Latin language terms and/or Japanese language terms are also included. Within the list, the indication of the provenance of the term (i.e. its source) is also included. An active ingredient TermID will be assigned to each unique term. The following approach will be used for the mapping:
Mapping of synonyms will be performed on the level of both the active moiety and the active ingredient where applicable. Herbal substances will be mapped on the following principles: - Botanical scientific name according to the Latin binomial system (genus + species) - The author (e.g., Linnaeus, abbreviated L.) if known, - The plant parts (if known) and - The process (when applicable, and if known) Herbal preparations will be mapped on the basis of the standardized treatments (for instance extraction, distillation, expression, fractionation, purification, concentration or fermentation) as described in the official Pharmacopoeias of the three regions. For extractions, the solvent will also be specified. For vaccine antigens the mapping of active substances will be based on the following principles: - Conformity with the pharmacopoeia monograph terminology for vaccine antigens in the regions; - For non-pharmacopoeia active substances, according to the formal Latin/Greek name and/or the disease being protected against. For bacteria and viruses, the strain serotype or other appropriate sub-species the designation will also be mapped with the name of each antigen, if relevant. In addition, the nature of any cellular system(s) used for production, and if relevant the use of recombinant DNA technology (including the use of the expression ‘produced in XXX cells <by recombinant DNA technology>) will be mapped, following the pattern set by the following examples: - ‘produced in human diploid (MRC-5) cells’ - ‘produced in Escherichia coli cells by recombinant DNA technology’ - ‘produced in chick-embryo cells’ The inclusion of a mention of the production process in vaccine active substance names will be mapped at the level of the following terms: - ‘live, attenuated’ (in the case of vaccines containing living micro-organisms) - ‘inactivated’ (in the case of vaccines containing killed micro-organisms). |
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Scope: |
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The Pharmaceutical Dose Form Controlled Vocabulary includes
pharmaceutical dose form terms of standard terminologies in use
by the regulators in the ICH regions and observer countries.
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Definitions: |
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A Dose Form is defined as the physical
manifestation [“entity”] that contains the active and/or
inactive ingredients that deliver a dose of the medicinal
product. The key defining characteristics of the Dose Form can
be the state of matter, delivery method, release
characteristics, and the administration site or route for which
the product is formulated. |
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A Pharmaceutical Dose Form is the form in which a
pharmaceutical product is presented in the medicinal product
package as supplied by the marketing authorization
holder/manufacturer/distributor. |
Methodology: |
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A comprehensive list of Dose Form terms has been collected, which includes:
Within the list, the indication of the provenance of the term (i.e. its source) will also be included. Tasks to be undertaken include:
The dose form description applies to only one concept at a time. Therefore, items that are marketed as packs containing more than one medicinal product will not themselves have a “combination dose form”, but each medicinal product within them will have a dose form description. This will avoid terms such as “pessary + cream” or “powder + solvent”. |
Scope: |
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The Routes of Administration Controlled Vocabulary includes
routes of administration terms of standard terminologies in use
by the regulators in the ICH regions and observer countries and
defined in the ICH E2B(M) guideline (version 4.4.1 includes the
Post Step 4 corrections agreed by the Steering Committee on 5
February 2001). |
Definitions: |
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The Route of Administration indicates the
part of the body through or into which, or the way in which, the
medicinal product is intended to be introduced. |
Methodology: |
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A comprehensive list of Route of Administration terms has been collected and includes:
Each term is given an identifier, a description and relationships to other terms within the terminology. Tasks undertaken include:
Synonymous terms are identified and “annotated” e.g. ocular use and ophthalmic use.
-
Where, within one region, two or more terms (e.g. a current term
and a historic non-current term) refer to the same route of
administration, these terms were specified in sequence and
separated by the symbol "/". The preferred or current term is
specified as the first term, e.g. ocular use/ophthalmic use for
EU or unknown/unassigned for the US.
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Scope: |
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The Units and Measurements Controlled Vocabulary includes units
and measurements in use by the regulators in the ICH regions
and observer countries and defined in the ICH E2B(M) guideline
(version 4.4.1 includes the Post Step 4 corrections agreed by
the Steering Committee on 5 February 2001). |
General Conventions: |
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The International System of Units (SI) and the Units and
Measurements as described in the E2B(M) guideline, (version
4.4.1 includes the Post Step 4 corrections agreed by the
Steering Committee on 5 February 2001) are followed in the ICH
regions and observer countries. Additional, region specific
units are in use specifically regarding biological and
microbiological units. |
Methodology: |
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A comprehensive list of Units and Measurements has been collected and includes:
Each unit and measurement is given an identifier, a description, a symbol and relationships to other terms within the terminology. Tasks undertaken include:
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This chapter describes the data elements for the electronic transmission of a core set of medicinal product information.
The data elements as presented in this guideline refer to the consolidated core data sets of medicinal products as defined in the scope of this guideline, chapter 1.3.
These data elements are based on the regional standards already established by these regulators to support the local data collection process and do not replace or supersede the regional standards or legal requirements for data collection between the regulators and pharmaceutical companies.
As a result, a medicinal product is characterized
in the frame of this guideline
as follows:
In order to facilitate the understanding of the relationship of the data elements described in this chapter, a conceptual model is included as follows:
Figure - Conceptual Model of the ICH M5 MedID and Data Element Set
This conceptual model does not define the actual message specifications for the exchange format of MedIDs and the related ICH M5 data elements.
The figure provides the relationship between the ICH M5 data elements and the MedID.
There are relationships between entities, with a specific cardinality.
Each section and each element of the ICH M5 data element set is described in the following paragraphs.
As a general principle, it should be noted that depending on regional laws and regulations a formal marketing authorization might not be required for certain categories of medicinal products (e.g. certain OTC drugs, ‘grandfather’ drugs). For these medicinal products the same principles apply as for ‘authorised’ medicinal products.
2.3.1.1 Medicinal Product Identifier (MedID)
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User Guidance: |
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The MedID as defined in chapter 2.1.1 of the medicinal product and as presented in the ICH M5 data element set should be provided in this field. As a general rule, the MedID should be maintained in any re-transmission of the same medicinal product information. |
Type: |
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Mandatory |
Example: |
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FR-123456-X |
2.3.2.1 Medicinal Product Name
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Definition: |
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The name
assigned to a medicinal product as approved by the regulator
of the country of authorization. |
User Guidance: |
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The naming of a medicinal product differs in the ICH regions and observer countries. The full and complete medicinal product name as approved by the regulator of the country or territory of authorization and as appearing on the package of the medicinal product, the container or the package insert should be provided in this field. |
Synonyms: |
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Proprietary Medicinal Product Name (ICH E2B(M)) Name of the Medicinal Product Product Name |
Type: |
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Mandatory |
Examples: |
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Lithium Carbonate liq. Paediatric Company D |
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ABC Tabs 500 Company B |
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Vinblastine Sulphate Injection Solution 10mg/ml |
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Tri-Product C Forte |
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Product X Oral Gel |
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BRANDX 100 U/ml Concentrate for solution for infusion-Intravenous use Vial (glass) 5 ml (100 U/ml) 1 vial |
2.3.2.2 Medicinal Product Short Name
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Definition: |
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The medicinal product name without the trademark or the name of the marketing authorization holder or any other descriptor (e.g. strength, dosage form, user group, route of administration). |
User Guidance: |
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The name assigned to a medicinal product as approved by the regulator of the country or territory of authorization, without the trademark or the name of the marketing authorization holder or any other descriptor should be provided in this field. For medicinal products which do not require prior marketing authorization under regional law, the medicinal product name without the trademark or the name of the manufacturer/distributor or any other descriptor should be provided in this field. |
Synonyms: |
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Trade Name |
Type: |
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Optional |
Example: |
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Lithium Carbonate |
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ABC |
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Vinblastine Sulphate |
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Tri-Product C |
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Product X |
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BRANDX |
2.3.3 Marketing Authorization Holder/Manufacturer/Distributor Section
Definitions: |
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Marketing
Authorization Holder (MAH) |
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Manufacturer
(MF)
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Distributor |
2.3.3.1
Name
of the Marketing Authorization Holder or Manufacturer or
Distributor
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User Guidance: |
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The full and complete name of the marketing authorization holder of an authorized medicinal product as appearing on the package of a medicinal product, the container or the package insert should be provided in this field. For medicinal products which do not require prior marketing authorization under regional law, the full and complete name of the manufacturer/distributor, as appearing on the package, the container or the package insert, should be provided in this field. |
Type: |
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Mandatory |
2.3.3.2
Marketing Authorization Holder or Manufacturer or Distributor
Identifier
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User Guidance: |
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The identifier assigned by a regulator of a region or observer country to a marketing authorization holder for authorized medicinal products, or to the manufacturer/distributor for medicinal products that do not require prior marketing authorization, should be provided in this field. |
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Type: |
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Optional |
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2.3.3.3 Country of the Marketing Authorization Holder or Manufacturer
or Distributor
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User Guidance: |
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The two letter ISO 3166 country code of the country in which the marketing authorization holder is located should be provided in this field. For medicinal products that do not require prior marketing authorization under regional law, the two letter ISO 3166 country code of the country in which the manufacturer/distributor is located should be provided in this field. |
Type: |
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Mandatory |
Definitions: |
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The marketing authorization information of the medicinal product as granted by the regulator in the respective territory/country should be provided. For medicinal products that do not require prior marketing authorization under regional law, the section should be completed as specified. |
2.3.4.1 Marketing Authorization Number
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Definition: |
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The marketing authorization number of the medicinal product as granted by the regulator in the respective territory/country. |
User Guidance: |
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The marketing authorization number of the medicinal product as granted by the regulator in the respective territory/country should be provided. For medicinal products that do not require prior marketing authorization under regional law, a unique identifier should be assigned by the regulator and reflected in this field. |
Synonyms: |
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Authorization Number |
Type: |
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Mandatory |
2.3.4.2
Marketing Authorization Country
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Definition: |
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The marketing authorization country refers to the country/territory in which the marketing authorization was granted by the regulator of this country/territory. |
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User Guidance: |
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The medicinal product authorization country for the medicinal product should be provided as a two letter country code (ISO 3166). For medicinal products in the United States and Japan the country code will be set as default to US or JP. For centrally authorized medicinal products in the European Union, the country code will be set to EU.
For medicinal products that do not require prior marketing
authorization under regional law, the country of marketing
should be specified in this field.
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Synonyms: |
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Authorization Country License Country |
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Type: |
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Mandatory |
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2.3.4.3
Marketing Authorization Date
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Definition: |
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The date on which the marketing authorization was granted by the regulator of the respective country/territory. |
User Guidance: |
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The date on which the authorization for the medicinal product was granted by the regulator should be provided in this field. A complete date consisting of day, month and year should be specified. For medicinal products that do not require prior marketing authorization under regional law, a default date will be provided by the regulator of the region in this field. |
Synonyms: |
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Authorization Date License Date |
Type: |
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Mandatory |
2.3.4.4
Marketing Authorization Withdrawal Date
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Definition: |
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The date on which the authorization for the medicinal product
was withdrawn/revoked by the
regulator of the country/territory or by the marketing
authorization holder/manufacturer/distributor, depending on
the regulatory requirements in the region or observer
countries. |
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User Guidance: |
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The date on which the authorization for the medicinal product was withdrawn/revoked by the regulator of the respective country/territory or by the marketing authorization holder/manufacturer/distributor should be provided in this field. A complete date consisting of day, month and year should be specified. For medicinal products that do not require prior marketing authorization under regional law, this field is not applicable.
This information should be provided if applicable. |
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Synonyms: |
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Withdrawal Date |
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Type: |
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Optional |
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Definition: |
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The pharmaceutical product section reflects the active ingredient(s), strength(s), pharmaceutical/dosage form(s) and routes of administration(s) that constitute a medicinal product. A medicinal product can consist of one or several pharmaceutical products, given to (or taken by) a patient with a therapeutic or diagnostic intent. |
User Guidance: |
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The Pharmaceutical Product Section is repeatable to allow for the entry of each pharmaceutical product that constitutes the medicinal product.
The exact composition at the level of the active ingredient(s),
the strength of the ingredient(s), the pharmaceutical dose
form and the route(s) of administration should be provided for
each pharmaceutical product. |
Examples: |
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Product A
Pharmaceutical Product: |
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Product Z ®
Pharmaceutical Product 1:
Pharmaceutical Product 2: |
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Product Combi ®[1]
Pharmaceutical Product 1:
Pharmaceutical Product 2: Route of Administration: Cutaneous Use |
User Guidance: |
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The active ingredient section is a repeatable section. If a pharmaceutical product contains more than one active ingredient, the section should be repeated for each active ingredient. |
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Type: |
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Mandatory |
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2.3.6.1 Active Ingredient Term
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User Guidance: |
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The active ingredient as reflected in the medicinal product labeling should be provided as a standard term in line with the ICH M5 Active Ingredients Controlled Vocabulary in this field. |
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Type: |
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Mandatory |
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2.3.6.2 Active Ingredient TermID
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User Guidance: |
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The ICH M5 Active Ingredients Controlled Vocabulary TermID for the active ingredient term should be provided in this field. |
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Type: |
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Mandatory |
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Definition: |
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The content of the active ingredient expressed quantitatively per dosage unit, per unit of volume or per unit of weight, according to the pharmaceutical dose form. |
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User Guidance: |
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This section includes the strength of the active ingredient. |
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Synonyms: |
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Concentration, Unit dose |
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Type: |
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Mandatory |
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Example: |
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Solid forms: |
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2.3.6.3.1 Strength Type |
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Definition: |
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Descriptor that specifies the strength type of the active ingredient of a medicinal product. |
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User Guidance: |
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For some medicinal products, the exact dose strength cannot be indicated and is therefore expressed as a concentration range or as ‘not greater than’ or as ‘not less than’ a particular value. The following four descriptors are available to express the strength of an active ingredient: Equal: The dose strength is indicated as a unique value in the ‘Strength Value 1’ field. Range: If the strength is expressed as a range, the minimum value and the maximum value of the dose strength are indicated in the ‘Strength Value 1’ field and in the ‘Strength Value 2’ field. Not greater than: If the dose strength is expressed as “not greater than”, the maximum dose strength is indicated in the ‘Strength Value 1’ field. Not less than: If the dose strength is expressed as “not less than”, the minimum dose strength is indicated in the ‘Strength Value 1’ field. |
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Type: |
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Mandatory |
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2.3.6.3.2 Strength Value 1
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User Guidance: |
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The numeric value of the dose strength of the active
ingredient as specified in the medicinal product labeling
should be indicated in this field. For numeric values with
decimal fractions, a full stop should be used. |
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Type: |
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Mandatory |
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2.3.6.3.3 Strength Value 2
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User Guidance: |
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The numeric value of the dose strength of the active ingredient as specified in the medicinal product labeling should be indicated in this field. For numerical values with decimal fractions, a full stop should be used. If the strength is expressed as a range, the maximum value of the dose strength should be specified in the field ‘Strength Value 2’. |
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Type: |
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Optional |
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2.3.6.3.4
Strength Unit Term
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User Guidance: |
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The strength unit symbol should be specified as the corresponding descriptor of the ICH M5 Units and Measurements Controlled Vocabulary.
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Type: |
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Mandatory |
2.3.6.3.5
Strength Unit TermID
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User Guidance: |
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The Unit and Measurement Controlled Vocabulary TermID of the corresponding unit and measurement term should be provided in this field. |
Type: |
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Mandatory |
2.3.6.3.6
Strength Description
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User Guidance: |
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This free text field can be used to describe a concentration range for some medicinal products where the exact dose strength cannot be structured in the Strength Section. |
Type: |
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Optional |
User Guidance: |
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This section refers to the pharmaceutical dose form. Each pharmaceutical product can have only one pharmaceutical dose form. Therefore, this section is not repeatable. |
2.3.7.1
Pharmaceutical Dose Form Term
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User Guidance: |
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The pharmaceutical dose form as reflected in the medicinal
product labeling should be provided as standard term in line
with the ICH M5 Pharmaceutical Dose Form Controlled Vocabulary
in this field.
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Synonyms: |
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Pharmaceutical Form E2B(M) |
Type: |
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2.3.7.2 Pharmaceutical Dose Form TermID
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User Guidance: |
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The ICH M5 Pharmaceutical Dose Form Controlled Vocabulary TermID of the corresponding pharmaceutical dose form term should be provided in this field. |
Type: |
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Mandatory |
User Guidance: |
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This section refers to the route(s) of administration of the pharmaceutical product. The route of administration section is a repeatable section. |
2.3.8.1 Route(s) of Administration Term
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User Guidance: |
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The route of administration as reflected in the medicinal product labeling should be provided as standard term in line with the ICH M5 Route of Administrations Controlled Vocabulary in this field. |
Type: |
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Mandatory |
2.3.8.2 Route of Administration TermID
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User Guidance: |
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The ICH M5 Routes of Administration Controlled Vocabulary TermID of the corresponding pharmaceutical dose form term should be provided in this field. |
Type: |
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Mandatory |
User Guidance: |
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This section contains information related to the maintenance of MedIDs and the medicinal product information as specified in the ICH M5 data element set. |
2.3.9.1 Maintenance Operator
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Definition: |
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The maintenance operator:
Three types of maintenance operators are available:
This operator applies for the initial transmission of the MedID and the related ICH M5 data elements for a specific medicinal product.
This operator applies for the transmission of the MedID and the related ICH M5 data elements for a specific medicinal product, when previously transmitted information needs to be updated.
This operator applies for the transmission of the
MedID and the related ICH M5 data elements for a
specific medicinal product, when previously
transmitted information needs to be nullified. |
User Guidance: |
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In this case the status of the MedID and the complete ICH M5 data element set is ‘Current’.
In this case the status of the most recently transmitted ICH M5 data element set for the MedID is ‘Current’. The status of the previous ICH M5 data element set(s) is ‘Replaced’.
In particular the maintenance operator ‘Nullify’ should be used if a MedID previously reported is wrong. The status of the MedID and the ICH M5 data element set is ‘Nullified’. |
Type: |
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Mandatory |
2.3.9.2
Operation Date
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Definition: |
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The date at which the maintenance operation is effective. |
User Guidance: |
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The operation date should be specified for any transmission of a MedID and the related ICH M5 data element set including the applicable maintenance operator. Based on the maintenance operator and the operation date, the status of each MedID and the related ICH M5 data element set can be maintained i.e. entries can be flagged as ‘Current’, ‘Replaced’ or ‘Nullified’. |
Type: |
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Mandatory |
2.3.9.3
Operation Comments
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User Guidance: |
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|
Comments on the maintenance operator can be provided, e.g. the reason for an update or a nullification of a MedID and the ICH M5 data element set. |
Type: |
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Optional |
This glossary defines the way in which certain terms are used for the purpose of the guideline and for which no specific definition has been provided within the guideline itself.
In addition this glossary provides an overview of acronyms used throughout the document.
Glossary of Terms
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|
Medicinal Product Package |
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Definition: |
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Delivery unit of a medicinal product in an outer container. |
Synonyms: |
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|
Package presentation |
Country or Territory |
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Definition: |
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A country or territory is defined as geographical, political or economic area. |
Acronyms
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CA |
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Canada |
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CAS |
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Chemical Abstract Service Number |
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EMEA |
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European Medicines Agency, EU |
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EU |
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European Union |
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FDA |
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Food and Drug Administration, US |
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HL7 |
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Health Level 7 |
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ICH |
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International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use |
ICH M5 EWG |
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International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use M5 Data Elements and Standards for Drug Dictionaries Expert Working Group |
ICH E2B (M) |
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International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use E2B(M): Clinical Data Management: Data Elements for Transmission of Individual Case Safety Reports |
INN |
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International Non-proprietary Name |
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ISO |
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International Organization for Standardization |
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IUPAC |
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International Union of Pure and Applied Chemistry |
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JAN |
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Japanese Accepted Name |
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JP |
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Japan |
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MAH |
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Marketing Authorization Holder |
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MedID |
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Medicinal Product Identifier |
MF |
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Manufacturer |
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MHLW |
|
Ministry of Health, Labour and Welfare, Japan |
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NDC |
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National Drug Code |
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NIST |
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National Institute of Standards and Technology |
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OTC |
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Over the Counter |
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PhPID |
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Pharmaceutical Product Identifier |
SI |
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International System of Units |
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TermID |
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Terminology Identifier of the ICH M5 controlled Vocabulary |
US |
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United States |
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USAN |
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United States Adopted Name |
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USP |
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United States Pharmacopoeia |
Canada |
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|
The Food and Drugs Act and Regulations and related Health Canada Guidelines: http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/index_e.html The Natural Health Product Regulations and related Health Canada Guidelines: http://www.hc-sc.gc.ca/hpfb-dgpsa/nhpd-dpsn/index_e.html
|
European Union |
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|
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (Official Journal L 311, 28/11/2001 p. 67 - 128) http://pharmacos.eudra.org/F2/eudralex/vol-1/DIR_2001_83/DIR_2001_83_EN.pdf Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004 amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use (Official Journal L 136, 30/4/2004, p. 85 - 90). http://pharmacos.eudra.org/F2/eudralex/vol-1/DIR_2004_24/DIR_2004_24_EN.pdf Consolidated Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use as amended by Directive 2002/98/EC, Directive 2004/24/EC and Directive 2004/27/EC) http://pharmacos.eudra.org/F2/eudralex/vol-1/CONSOL_2004/Human%20Code.pdf Notice to Applicants Volume 2 A, Medicinal Products for Human Use, Version 2 - December 2004 http://pharmacos.eudra.org/F2/eudralex/vol-2/home.htm
A Guideline on Summary of Product Characteristics, December 1999, (Doc. Ref. Notice to Applicants, Final – revision 0) http://pharmacos.eudra.org/F2/eudralex/vol-2/C/SPCGuidRev0-Dec99.pdf Guideline on Pharmaceutical Aspects of the Product Information for Human Vaccines, 26 November 2003 (Doc. Ref. EMEA/CPMP/BWP/2758/02) http://www.emea.eu.int/pdfs/human/bwp/275802en.pdf Guideline on the Acceptability of Invented Names for Human Medicinal Products Processed through the Centralized Procedure, London, 14 September 2004 (Doc. Ref. CPMP/328/98, Revision 4) http://www.emea.eu.int/pdfs/human/regaffair/032898r4en.pdf Guideline on the Chemistry of new Active Substances, 17 December 2003 (Doc. Ref. CPMP/QWP/130/96 Rev. 1) http://www.emea.eu.int/pdfs/human/qwp/013096en.pdf Standard Terms: Dosage Forms, Routes of Administration and Containers, EDQM, Fifth Edition, December 2004, Version 5.0.0
EudraVigilance Medicinal Product Dictionary (EVMPD) Version
2.0
http://eudravigilance.emea.eu.int/human/docs/EVMPD%20Technical
EudraVigilance Medicinal Product Dictionary (EVMPD) Version
2.0
http://eudravigilance.emea.eu.int/human/docs/EVMPD%20Message
EudraVigilance (EV) Access simple Database Version 2.0 8 November 2004 (Doc. Ref: EMEA/140327/2004)
http://eudravigilance.emea.eu.int/human/docs/EV%20Access%20Simple%20
EudraVigilance (EV) Access Simple Database Version 2.0 Forms Documentation, 31 January 2005, (Doc. Ref: EMEA/35416/2005)
http://eudravigilance.emea.eu.int/human/docs/EVAccessSimple%20
EudraVigilance (EV) Access Simple Database Version 2.0 Step by Step Guide
8 December 2004, (Doc. Ref: EMEA/191986/2004)
http://eudravigilance.emea.eu.int/human/docs/EV%20Access%20Simple%20 |
Japan |
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Japanese Pharmacopoeia, Fourteenth Edition, Part 1, General Rules For Preparation http://jpdb.nihs.go.jp/jp14e/14data/General_Rules_for_Prepart1.pdf
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United States |
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Guidance for Industry Providing Regulatory Submissions in Electronic Format — Content of Labeling http://www.fda.gov/cder/regulatory/guidance
Release Notes for SPL Schema PORR_MT050020 (3.20.05) FDA SPL Schema for Implementation http://www.fda.gov/oc/datacouncil/spl.html
CaCore 2.0 Technical Guide, National Cancer Institute, Center for Bioinformatics, U.S. Department of Health and Human Services ftp://ftp1.nci.nih.gov/pub/cacore/caCORE2.0_Tech_Guide.pdf
A guide to RXNorm, United States National Library of Medicine, National Institute of Health http://www.nlm.nih.gov/research/umls/rxnorm_guide.pdf
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[1] The use of ‘Mandatory’ in the remainder of this document refers to technical and not legal requirements.
[1] Version 4.4.1 includes the Post Step 4 corrections agreed by the Steering Committee on 5 February 2001
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Date created: September 2, 2005