Name | Name of product / substance / regulatory event | Product names are normally the full
brand name. For vaccines, this includes the letters that may
indicate an indicated disease. Where the information concerns a
range of products e.g. a dog vaccine range, the name will only
give the range brand name and 'range' will be given in
ID Factor 2 Substance names are the INN, spelt
as in the source information Regulatory names are a single term that best describes the
information item |
ID Factor 2 | Additional information that is needed to identify the subject
of the information item. | Where the information concerns only
a certain presentation e.g. 30mg, this is recorded here. Where the information concerns a
range of products e.g. a dog vaccine range, the name will only
give the range brand name and 'range' will be given in
ID Factor 2. Also used to record the EMA procedure number, especially for
new products or substances |
Synopsis | Brief description of the information |
|
Event date | The date that best indicates the date the event occurred or the
information became available | Normally the date on documents or
press releases at the time the event occurred. Where there is a significant
difference between the date on a document and its release the
document release date will be listed as the event date (for
example, EPARs)
|
Hyperlink 1, 2, 3 | Link to the source of information item (1) and where possible
related information (2, 3) |
|
Product information link | Link to the SPC or similar product information |
|
Product type | Describes use category of product or substance | Includes: Alimentary tract, Antibiotic, ,Antifungal,
Anti-inflammatory, Cardiovascular / Respiratory, Dietary
supplements / Metabolic / Fluids, Ectoparasiticide, Endectocide,
Endoparasiticide, Excipient, Hormonal, Intramammary,
Musculo-skeletal, Neurological , New technology, Recombinant
vaccine, Renal / Urinary tract, Topical combined (eye, ear, skin),
Unknown, Vaccine combined Live & Inactivated, Vaccine
Inactivated, Vaccine Live , Vaccine not specified |
Species | Indicated Species, also food basket & related classes for
MRLs. | Includes: Cat, Dog, Horse / equine (not food), Horse / equine
(food), Equine other, Pigs / porcine, Cattle / bovine, Sheep /
ovine, Goat / caprine, Chicken, Turkey, Avian other (food), Rabbit
(food), Salmon, Other finned fish, Bees, Other (food), Other
(small pets ,birds, exotics, non-food), Milk, Eggs, Honey, All
food species (MRL), MRL out of scope, Unknown |
Item category | Main subject headings for the monthly report. Includes animal
species groups (e.g. Ruminant) and regulatory headings (e.g.
Safety) | Includes: Aquatic, Avian, Swine, Ruminants, Pets, Antimicrobial
Resistance, Horses, General, Quality, Safety, Efficacy,
Immunologicals New Technologies, Pharmacovigilance |
Authorised / Not Authorised | MA status | Products only |
MA Number | Marketing Authorisation Number |
|
Procedure 1 | Regulatory procedures for authorising VMPs, MRLs | Includes: All procedures, N/A, CP, DCP, MRL, MRP, National,
Referral, |
Country 1 / RMS | Country or region in scope of Procedure 1; Reference member
state for MRP/DCP | Includes: All EU' All EU (CP),
All EU (CP/MRP), All EU (MRL), All EU (MS - DCP/MRP) Countries use their abbreviations: DE, UK, ES ... |
Procedure 2 | Procedures within those listed in Procedure 1 | Includes: All procedures, Extension,
Extrapolation, New Application, Parallel distribution, Product
information, Update, QRD, Referral Art 11, Referral Art 13,
Referral Art 30, Referral Art 33, Referral Art 34, Referral Art
35, Referral Art 39. 40, Referral Art 45, Referral Art 71,
Referral Art 78, Renewal, Review, Variation E, Variation Q,
Variation S, Variations (all) |
Country 2 | Concerned Member States | Countries use their abbreviations: DE, UK, ES |
Stage | To indicate, where possible, the presumed stage a procedure has
reached. |
|
Event descriptor | Describes the nature of the event | Includes: Consultation, Final Guidance, Information, Q/A,
Recommendation, Report, Update |
Document title |
|
|
Document ref | Reference number as printed on document |
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Critical date | Deadline or otherwise specific date | For example, final date for consultations |
Source organisation | Source of the information item |
|
Keywords | Only key words not otherwise included in the item information
data entry |
|
Report date | The monthly report in which the information item is presented |
|