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`EU COMMUNITY REGISTER OF MEDICINAL PRODUCTS
` -
`FREQUENTLY ASKED QUESTIONS
`
`
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`
`
`
`
`
`
`The purpose of these FAQ’s is to provide an overview on issues that have been frequently raised by the public
`in the context of the EU Community Register of Medicinal products. The information in this document is
`however, for guidance only, not complete, is simplified and may not be updated.
`Reference to the full legal texts can be found in the last question.
`
`
`
`April 2016
`
`WATSON LABORATORIES, INC. , IPR2017-01622, Ex. 1049, p. 1 of 13
`
`

`

`CONTENTS
`
`EU COMMUNITY REGISTER OF MEDICINAL PRODUCTS - FREQUENTLY ASKED QUESTIONS .......................................................... 1
`
`WHAT PRODUCTS ARE AUTHORISED CENTRALLY BY THE EUROPEAN COMMISSION AND WHAT PRODUCTS BY THE
`NATIONAL AUTHORITIES OF THE MEMBER STATES? ...................................................................................................................... 4
`
`HOW IS THE EU NUMBER COMPOSED? .................................................................................................................................... 4
`
`HOW IS THE EMA (EMEA) PROCEDURE NUMBER COMPOSED? .............................................................................................. 4
`
`FOR CENTRALLY AUTHORISED PRODUCTS ...........................................................................................................4
`
`FOR REFERRALS: .................................................................................................................................................5
`
`FOR ORPHAN DESIGNATIONS: ..........................................................................................................................7
`
`WHY ARE THERE EU NUMBERS MISSING IN THE CHRONOLOGICAL SERIES? ........................................................................ 7
`
`WHY DOES THE EU NUMBERING OF PRODUCTS NOT FOLLOW THE CHRONOLOGICAL ORDER OF
`AUTHORISATION? .......................................................................................................................................................................... 7
`
`WHY IS THE PRODUCT I CAN BUY IN MY LOCAL PHARMACY NOT LISTED IN THE COMMUNITY
`REGISTER? ...................................................................................................................................................................................... 7
`
`WHY CAN’T I BUY THE PRODUCT LISTED IN THE COMMUNITY REGISTER IN MY LOCAL PHARMACY? .............................. 8
`
`WHY THE DATA ON THE PROCEDURES IN THE COMMUNITY REGISTER ARE NOT AVAILABLE THE DAY THE
`DECISION IS TAKEN? .................................................................................................................................................................. 8
`
`WHAT IS MEANT WITH MINOR - AND MAJOR VARIATIONS? ................................................................................................... 8
`
`CAN I BE ALERTED TO CHANGES IN THE EU COMMUNITY REGISTER FOR A SPECIFIC PRODUCT OR
`GROUP OF PRODUCTS? .............................................................................................................................................................. 8
`
`WHAT IS INN? ............................................................................................................................................................................... 9
`
`WHAT IS EPAR? ............................................................................................................................................................................. 9
`
`WHAT IS ATC? .............................................................................................................................................................................. 9
`
`WHAT LANGUAGES ARE MEANT WITH THE CODES IN THE LANGUAGE SELECTORS?........................................................... 9
`
`WHY ISN'T THERE A COMMISSION DECISION FOR ALL VARIATIONS? ........................................................................................... 10
`
`WHAT DO CONTAIN THE ANNEXES TO A DECISION? ............................................................................................................. 10
`
`FOR CENTRALLY AUTHORISED PRODUCTS: ...................................................................................................10
`
`FOR REFERRALS: ...............................................................................................................................................11
`
`FOR ORPHAN DESIGNATIONS: ........................................................................................................................11
`
`WHY ARE PACKAGE PRESENTATIONS AND FULL EU NUMBERS NOT SHOWN IN THE COMMUNITY
`REGISTER? .................................................................................................................................................................................... 11
`
`WATSON LABORATORIES, INC. , IPR2017-01622, Ex. 1049, p. 2 of 13
`
`

`

`WHAT STATUS CAN A MEDICINAL PRODUCT HAVE? ............................................................................................................ 11
`
`CAN I MAKE A LINK TO THE LATEST ANNEXES FOR A CENTRALISED PRODUCT? ............................................................. 12
`
`WHY IS IRISH (GAELIC) MISSING IN THE COMMUNITY REGISTER? ..................................................................................... 12
`
`WHAT ARE PRODUCTS REGISTERED UNDER ARTICLE 126A OF DIR 2001/83/EC? ............................................................... 13
`
`WHERE CAN I FIND MORE INFORMATION ON HOW THE AUTHORISATIONS AND THE FOLLOW- UP
`PROCESSES WORK? ..................................................................................................................................................................... 13
`
`
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`
`
`WATSON LABORATORIES, INC. , IPR2017-01622, Ex. 1049, p. 3 of 13
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`

`

`WHAT PRODUCTS ARE AUTHORISED CENTRALLY BY THE EUROPEAN COMMISSION AND
`WHAT PRODUCTS BY THE NATIONAL AUTHORITIES OF THE MEMBER STATES?
`
`
`1. High-technology medicinal products, particularly those resulting from one of the following biotechnological
`processes:
`recombinant DNA technology,
`
`controlled expression of genes coding for biologically active proteins in prokaryotes and
`
`eukaryotes including transformed mammalian cells,
`hybridoma and monoclonal antibody methods.
`
`2. Medicinal products for veterinary use intended primarily for use as performance enhancers in order to
`promote the growth of treated animals or to increase yields from treated animals.
`3. Medicinal products for human use containing a new active substance for which the therapeutic indication
`is the treatment of any of the following diseases:
`acquired immune deficiency syndrome (AIDS),
`
`cancer,
`
`neurodegenerative disorder (like amyotrophic lateral sclerosis (ALS), Parkinson's disease,
`
`Alzheimer's disease, and Huntington's disease),
`diabetes
`
`and with effect from 20 May 2008
`auto-immune diseases and other immune dysfunctions,
`
`viral diseases.
`
`4. Medicinal products that are designated as orphan medicinal products
`
`All other products will be authorised by the national authorities from the Member States
`
`
`HOW IS THE EU NUMBER COMPOSED?
`
`
`EU/[1/2/3]/[YY]/[NNN]/[XXX]
`
`EU
`
`Indicates that it is a European centrally authorised or designated product [1/2/3]
`Human, 2 Veterinary, 3 Orphan medicinal product
`
`1
`
`[YY]
`
`last two digits of the year (98 for 1998; 04 for 2004)
`
`[NNN]
`
`chronological number of product authorised (NNNN from 1000 on)
`
`[XXX]
`
`number attributed to each individual package presentation of this product
`
`
`
`HOW IS THE EMA (EMEA) PROCEDURE NUMBER COMPOSED?
`
`FOR CENTRALLY AUTHORISED PRODUCTS
`
`
`[EMEA/EMA]/[H/V]/[XXX]/[Variation type]/[YYY]/[W/WS]/[ZZZ]/[G]
`
`
`[H/V]
`
`[XXX]
`[Variation type]
`
`
`
`H = Human medicinal products
`V = Veterinary medicinal product
`Chronological numbering of the products
`[missing] or /0000
`Authorisation
`
`Variation type I. A minor variation (existed 1995-2004).
`
`I
`
`WATSON LABORATORIES, INC. , IPR2017-01622, Ex. 1049, p. 4 of 13
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`

`

`Minor variation type A. Variations that may be implemented immediately by
`the marketing authorisation holder and must be notified within 12 months.
`Minor variation type I immediate notification. These are variations that may
`be implemented immediately by the marketing authorisation holder and
`must be notified immediately.
`Minor variation type B. Variations that are not type IA, IAin, II or X variations.
`They must be notified immediately and may be implemented by the
`marketing authorisation holder after 30 days if no objection is received.
`Minor variation type I that was part of a grouping. II
`Variation type II. Major variation.
`Notification according to article 61(3) of Directive 2001/83 of a change to an
`aspect of the labelling or package leaflet text (Annex III) with no change to
`the summary of product characteristics (Annex I).
`String update (vaccines).
`Renewal of the marketing authorisation after five years or annual renewal in
`case of a conditional marketing authorisation.
`Extension. As extensions to the marketing authorisation are considered
`changes to the active substance(s), to the strength, to the pharmaceutical
`form or to the route of administration.
`Transfer of marketing authorisation from one marketing authorisation holder
`to another.
`Annual reassessment of a product that is authorised under exceptional
`circumstances or authorised conditionally, where specific obligations, to be
`tested annually, are imposed.
`Variation after a Periodic safety update report (pharmacovigilance)
`
`IA
`
`IAin or
`IAIN
`
`IB
`
`IG
`II
`N
`
`SU
`R
`
`X
`
`T
`
`S
`
`PSUR or
`PSU or
`PSUV
`PSUSA
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`
`
`[YYY]
`[W/WS]
`
`[ZZZ]
`
`[G]
`
`Variation after Periodic safety update report with a single assessment for
`more than one product (pharmacovigilance)
`Chronological number of the procedures for this product
`Work-sharing: the same Type IB or Type II variations, or the same group of variations
`affecting more than one marketing authorisation from the same marketing authorisation
`holder, or group of companies having concluded agreements or exercising concerted
`practices concerning the placing on the market, in one application. When a group of
`variations only consists of type-IA or -IAIN variations affecting several marketing
`authorisations, this is considered as a 'group' of variations and not a 'work-sharing'
`procedure. However, it is possible to include a group of type-IA and -IAin variations with a
`type-IB or a type-II variation, which is submitted for a work-sharing procedure. In such
`cases, the review of the type-IA or -IAin variation is done as part of the work-sharing
`procedure.
`Chronological number for work-sharing not limited to this product or chronological
`referral number
`Grouping of minor variations for one marketing authorisation holder. A grouping of
`variations can concern several variations for one or several medicinal products of one
`marketing authorisation holder in one application. If for example the postal code of the
`marketing authorisation holder changes he may in one application apply for the change to
`all his products.
`
`
`Note that the EMA variation number EMEA/H/C/1206/II/34 may also be represented as
`EMEA/H/C/001206/II/034 with a varying number of leading zeros or as EMA/H/C/00001206/II/000034 in the
`documents.
`
`
`FOR REFERRALS:
`
`WATSON LABORATORIES, INC. , IPR2017-01622, Ex. 1049, p. 5 of 13
`
`

`

`
`[EMEA/EMA]/[H/V]/ A[-Article] /[XXX]
`
`
`[H/V]
`
`A[-Article]
`
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`
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`
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`
`
`
`
`
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`
`
`
`
`
`107i
`13
`
`20
`
`29
`
`29(4)
`
`H = Human medicinal products
`V = Veterinary medicinal product
`
`A procedure triggered by Article NN in the Pharmaceutical legislation, referred to as A-
`NN or without the article simply indicated as A, that may be applicable to one or a group
`of products both centralised and national. Most common values for [Article] are:
`
`
`For human products:
`107
`triggered when a Member State intends to vary, suspend or revoke the
`marketing authorisation for a medicine in its territory because of a safety issue
`[in application until 2012, now replaced by 107i]
`triggered by a Member State or EC in case of a safety issue
`triggered for a medicine that has been authorised by mutual recognition or via
`the decentralised procedure when there is disagreement between Member
`States on a variation
`triggered for medicines that have been authorised via the centralised procedure
`in case of concerns affecting the quality, safety or efficacy of the product
`triggered by a marketing-authorisation holder when applying for a new
`indication, new pharmaceutical form or new route of administration for use in
`children
`triggered when there is a disagreement between Member States regarding a
`medicine being evaluated during a mutual-recognition or decentralised
`procedure, on the grounds of a potential serious risk to public health
`triggered when harmonisation of national authorisations across the EU is needed
`triggered when the interest of the Union is involved, following concerns relating
`to the quality, safety or efficacy
`triggered when a Member State considered that action (variation, suspension or
`withdrawal) was needed on the grounds of the need to protect public health for
`a marketing authorisation that were granted via the mutual-recognition or
`decentralised procedure [discontinued as of 2012]
`triggered for a medicine that had been authorised by mutual recognition or via
`the decentralised procedure when there was disagreement between Member
`States on a variation (type IB) [discontinued as of 2010]
`triggered for a medicine that had been authorised by mutual recognition or via
`the decentralised procedure when there was disagreement between Member
`States on a variation (type II) [discontinued as of 2010]
`triggered by the marketing-authorisation holder for a medicine that had been
`authorised by mutual recognition or via the decentralised procedure when
`Member States could not accept the variation (type II) [discontinued as of 2010]
`
`29
`30
`
`36
`
`5(11)
`
`6(12)
`
`6(13)
`
`
`For veterinary products:
`13
`triggered for a medicine that has been authorised by mutual recognition or via
`the decentralised procedure when there is disagreement between Member States
`on a variation
`
`triggered when disagreement between Member States within the framework of
`the mutual- recognition or decentralised procedure
`triggered when disagreement between Member States within the framework of
`the mutual- recognition or decentralised procedure
`triggered when harmonisation of national authorisations across the EU is needed
`
`
`33
`
`34
`
`35
`
`WATSON LABORATORIES, INC. , IPR2017-01622, Ex. 1049, p. 6 of 13
`
`

`

`
`
`
`
`
`
`
`
`[XXX]
`
`36
`
`39
`40
`45
`
`in cases involving the interests of the Union or concerns relating to the protection
`of human or animal health or the environment
`follow-up referral
`follow-up referral
`triggered for medicines that have been authorised via the centralised procedure in
`case of concerns affecting the quality, safety or efficacy of the product
`triggered as a result of the evaluation of veterinary pharmacovigilance data, a
`Member State considers that a marketing authorisation should be suspended,
`withdrawn or varied to restrict the indications or availability, amend the posology,
`add a contraindication or add a new precautionary measure
`chronological referral number
`
`78
`
`
`The EMEA procedure numbers for referrals may be represented in different ways in the documents over time
`the number EMEA/V/A-34/88 can also be found as EMEA/V/A/88/Art.34, EMEA/V/A/88 or even EMEA/V/R/88
`or EMEA/V/R88. In these cases the numbers have, where possible, been standardized in the Community
`Register.
`
`FOR ORPHAN DESIGNATIONS:
`
`
`[EMEA/EMA]/OD/[XXX]/[YY]
`
`
`[XXX]
`
`[YY]
`
`
`
`Chronological number restarting at 001 every year
`
`last two digits of the year (98 for 1998; 04 for 2004)
`
`
`WHY ARE THERE EU NUMBERS MISSING IN THE CHRONOLOGICAL SERIES?
`
`
`Sometimes a marketing authorisation holder decides to withdraw an application for a new authorisation in a late
`stage of the authorisation process, long after the EU number has been designated. EU numbers are never re-
`used.
`
`
`WHY DOES THE EU NUMBERING OF PRODUCTS NOT FOLLOW THE CHRONOLOGICAL
`ORDER OF AUTHORISATION?
`
`
`The EU number is attributed in the course of the evaluation process by the Agency because the Annexes that
`are needed for a full evaluation by the Agency, Commission and Member States contain these EU numbers. If
`the decision making process is held up for any reason in a later stage (scientific concerns, objection by Member
`States, legal issues etc.) the final authorisation may sometimes be delayed for many months.
`
`
`WHY IS THE PRODUCT I CAN BUY IN MY LOCAL PHARMACY NOT LISTED IN THE
`COMMUNITY REGISTER?
`
`
`The Community Register only contains the centrally, for all EU Member States, by the European Commission
`since 1995 authorised products and not the nationally authorised products in every Member State of the EU.
`
`
`WATSON LABORATORIES, INC. , IPR2017-01622, Ex. 1049, p. 7 of 13
`
`

`

`WHY CAN’T I BUY THE PRODUCT LISTED IN THE COMMUNITY REGISTER IN MY LOCAL
`PHARMACY?
`
`
`The Community Register only contains the centrally, for all EU Member States, by the European Commission
`since 1995 authorised products. The marketing authorisation holder has the right to sell the product in any
`Member State, not the obligation. Also the actual marketing of the product depends on many factors as: the
`price and reimbursement (often to be negotiated with the national health systems), availability and price of
`competitive products, local habits of patients and healthcare professionals etc.
`
`
`WHY THE DATA ON THE PROCEDURES IN THE COMMUNITY REGISTER ARE NOT
`AVAILABLE THE DAY THE DECISION IS TAKEN?
`
`
`Commission Decisions only enter into force once they have been notified to whom the Decision is addressed.
`The Commission waits until the proof of notification is received before the Decision will be published.
`Publication will generally be done the first working day after proof of notification is received.
`
`
`WHAT IS MEANT WITH MINOR - AND MAJOR VARIATIONS?
`
` A
`
` variation is considered to be minor if there is a minor or no impact on the quality, safety or efficacy of a
`medicinal product (for example change in the address of the marketing authorisation holder).
`A variation is considered to be major if there is a significant impact on the quality, safety or efficacy of a
`medicinal product (for example change in indication of the medicinal product or the addition of a new one).
`
`
`CAN I BE ALERTED TO CHANGES IN THE EU COMMUNITY REGISTER FOR A SPECIFIC
`PRODUCT OR GROUP OF PRODUCTS?
`
`
`News feeds (also called RSS feeds) are available for the Community Register of Medicinal Products for both
`individual products as for different product groups. This opens the possibility to be alerted to changes in the
`Community register as soon as they are published.
`How these news feeds are handled on your computer depends on the internet browser you use, all browsers
`do have integrated news feed capabilities; you can also use a dedicated news feed application independent
`from your internet browser.
`
`For subscription to a news feed for a specific medicinal product, human, veterinary or orphan, go to the
`specific page for that product and press the RSS feed button behind the name of the product. You will be
`directed to the news feed page for that product where you may subscribe. These feeds give all changes about
`the concerned product, whether new documents are available or not. These feeds are divided into two
`categories, the updates with new documents (Commission Decisions or Annexes) and updates without new
`documents.
`Note that RSS feeds are only available for active or suspended products, not for withdrawn products.
` News feed for all new published documents, human, veterinary or orphan.
`This feed is divided into three categories: Human products (including referrals), Orphan designations
`and Veterinary products (including referrals).
` News feed for Human medicinal products.
`This feed only alerts to changes in the status of human medicinal products (new products,
`withdrawals, refusals, suspensions).
` News feed for Veterinary medicinal products.
`This feed only alerts to changes in the status of veterinary medicinal products (new products,
`withdrawals, refusals, suspensions).
`
`WATSON LABORATORIES, INC. , IPR2017-01622, Ex. 1049, p. 8 of 13
`
`

`

` News feed for Orphan medicinal products.
`All new documents concerning orphan designations, removals and transfers.
` News feed for Referral procedures concerning human and veterinary medicinal products.
`This feed is divided into two categories: Human products and Veterinary products.
`Note that referral procedures concerning products authorised through the centralised procedure are
`placed under the concerned centralised products.
`
`
`To access the general news feed pages see:
`http://ec.europa.eu/health/documents/community-register/html/index_rss_en.htm
`
`WHAT IS INN?
`
`
`INN means International Non-proprietary Name, a name used to facilitate the identification of pharmaceutical
`substances. In general the INN is much shorter and simpler than the chemical or systematic name. For example
`the INN ‘desloratadine’ has the systematic name ‘8-chloro-6,11-dihydro-11-(4-piperdinylidene)- 5H-
`benzo[5,6]cyclohepta[1,2- b]pyridine’. Each INN is a unique name that is globally recognized, is public
`property and is established in collaboration the WHO (World Health Organisation). A non-proprietary name is
`also known as a generic name.
`
`
`WHAT IS EPAR?
`
`
`European Public Assessment Report: a set of documents describing the evaluation of a medicine authorised via
`the centralized procedure, including the product information, published by the European Medicines Agency.
`
`
`WHAT IS ATC?
`
`
`ATC means Anatomical Therapeutic Chemical Classification System and is used for the classification of active
`ingredients of drugs according to the organ or system on which they act and their therapeutic, pharmacological
`and chemical properties. It is controlled by the World Health Organization Collaborating Centre for Drug
`Statistics Methodology (WHOCC).
`
`
`WHAT LANGUAGES ARE MEANT WITH THE CODES IN THE LANGUAGE SELECTORS?
`
`WATSON LABORATORIES, INC. , IPR2017-01622, Ex. 1049, p. 9 of 13
`
`

`

`
`Bulgarian (български)
`BUL
`Czech (čeština)
`CES
`Danish (dansk)
`DAN
`German (Deutsch)
`DEU
`Greek (ελληνικά)
`ELL
`English (English)
`ENG
`Spanish (Español)
`SPA
`Estonian (eesti keel)
`EST
` Finnish (suomi)
`FIN
`French (français)
`FRA
`Croatian (hrvatski)
`HRV
`Hungarian (Magyar)
`HUN
`Italian (italiano)
`ITA
`Lithuanian (lietuvių kalba)
`LIT
`Latvian (latviešu valoda)
`LAV
`MLT Maltese (Malti)
`NLD
`Dutch (Nederlands)
`POL
`Polish (polski)
`POR
`Portuguese (Português)
`RON
`Romanian (română)
`SLK
`Slovak (slovenčina)
`SLV
`Slovenian (slovenščina)
`SWE
`Swedish (svenska)
`
`
`WHY ISN'T THERE A COMMISSION DECISION FOR ALL VARIATIONS?
`
` A
`
` minor or major change may take place in the technical dossier of the product without this being reflected in
`the Annexes to the Commission Decision. If e.g. a major change is made to the manufacturing process of the
`active substance then there is a significant impact on the quality, safety or efficacy of a medicinal product, but
`because no information about the manufacturing process is contained in the annexes, there is no need to
`change the original Commission Decision.
`Minor variations where a change in Annexes is needed may sometimes be implemented immediately by the
`marketing authorisation holder but are only updated in a later Commission Decision.
`
`
`WHAT DO CONTAIN THE ANNEXES TO A DECISION?
`
`Integer parts of the Decisions are the Annexes that contain:
`
`FOR CENTRALLY AUTHORISED PRODUCTS:
`
`
`Annex I
`
`Annex II
`
`Annex III
`
`Annex IV[optional]
`
`
`
`Summary of product characteristics as the name, composition, pharmaceutical form,
`indication, clinical particulars and marketing authorisation holder.
`Data on the manufacturer of the active substance, the conditions and restrictions
`regarding supply and use and conditions and the requirements of the marketing
`authorisation.
`Labelling (what is marked on the different packaging's of the product) and full text of the
`package leaflet.
`Specific obligations imposed if a product has a conditional or exceptional marketing
`authorisation.
`
`WATSON LABORATORIES, INC. , IPR2017-01622, Ex. 1049, p. 10 of 13
`
`

`

`FOR REFERRALS:
`
`
`Annexes can be, but are not limited to:
`List of the names, pharmaceutical forms, strengths, routes of administration and marketing
`
`authorisation holders of the concerned products in the Member States
`Scientific conclusions and grounds for variation to the terms of the marketing authorisations
`
` Amendments to the product information and package leaflets of the medicinal products
`Conditions of the marketing authorisation
`
`Summary of the scientific evaluation of the follow-up conditions for the safe and effective use
`
` Revised conditions for the safe and effective use of the medicinal product
`
`FOR ORPHAN DESIGNATIONS:
`
`
`Orphan designation Decisions do generally not contain annexes.
`
`
`WHY ARE PACKAGE PRESENTATIONS AND FULL EU NUMBERS NOT SHOWN IN THE
`COMMUNITY REGISTER?
`
`
`Since the entry into force of the Variations Regulation 1234/2008 the marketing authorisation holder may in
`well- defined cases add or withdraw package presentations on informing the Agency (EMA) without informing
`the Commission and thus not being reflected in a Commission Decision until the next update. This would mean
`that the information in the Community Register could be incomplete or out-dated for up to one year. This
`information is now available on the Agency's website as soon as the Agency has been informed by the
`marketing authorisation holder. To find the presentations go to the Agency’s website and proceed as follows:
`Find medicine > Product page > Product information > EPAR - All authorised presentations
`
`
`WHAT STATUS CAN A MEDICINAL PRODUCT HAVE?
`
`
`Active
`
`
`Withdrawn
`
`
`Expired (sunset clause)
`
`
`Refused
`
`Suspended
`
`
`
`A marketing authorisation has been issued by the European Commission that is still
`valid. This does not necessarily mean that the product is (already) on the market. The
`marketing authorisation holder has the right to put the product on the market in any
`Member State, not the obligation.
`
`The marketing authorisation has been withdrawn by the European Commission on the
`basis of new scientific evidence (e.g. risk to public health) or on demand of the
`marketing authorisation holder itself for commercial reasons.
`
`If a medicinal product is not placed on the EU market within three years after its
`authorisation or when a product previously placed on the market is no longer actually
`present on the EU market for three consecutive years the sunset-clause leads
`automatically to the cessation of the validity without the need of a Commission
`Decision (exceptions may be granted by the Commission)
`
`A marketing authorisation has been requested but has been refused by the European
`Commission and has for that reason never been active
`A marketing authorisation has been issued by the European Commission that is still
`valid, but has been suspended. Reasons for suspension can be problems in the
`production phase of the product, newly discovered serious side-effects etc. After
`suspension will in general follow a (partial) lift of suspension or (partial) withdrawal of
`the product.
`
`WATSON LABORATORIES, INC. , IPR2017-01622, Ex. 1049, p. 11 of 13
`
`

`

`Not renewed
`
`
`
`
`A first marketing authorisation is normally valid for 5 years. After five years a renewal
`must be requested by the marketing authorisation holder. If this renewal is not
`requested the validity of the authorisation will cease automatically.
`
`CAN I MAKE A LINK TO THE LATEST ANNEXES FOR A CENTRALISED PRODUCT?
`
`
`
`
`Yes. A special link in the Community Register gives the possibility to use one entry point per medicinal product
`and retrieve the latest annexes (SPC, MAH data, COND, Packaging and PL) of a European centrally authorised
`medicinal product as published in the Community Register, human or veterinary, in any EU official language.
`This option was requested by some Member States, so they do not have to update their databases every time a
`new series of Annexes is issued by the EC.
`
`The files are called “h_direct_anx.htm” for human and “v_direct_anx.htm” for veterinary medicines.
`For no longer valid authorisations the file name must be preceded by the letter “x” (“xh_direct_anx.htm” for
`human and “xv_direct_anx.htm” for veterinary medicines).
`
`the domain is always http://ec.europa.eu/health/documents/community-register/html/ The hash data -
`characters added to a URL after a hash sign (#) - that can be added are:
`the EU sequential authorisation number (mandatory) , directly after the # sign in any number format “1”, “123”,
`”0005” or “006”
`the language (optional); in two letter ISO format preceded by an underscore “_fr” for French, “_de” for German
`etc., when omitted English is used.
`
`Examples:
`the last valid annex for the human product Ziagen EU number EU/1/09/112 can be retrieved in English with the
`URL: http://ec.europa.eu/health/documents/community-register/html/h_direct_anx.htm#112
`The French version by using:
`http://ec.europa.eu/health/documents/community-register/html/h_direct_anx.htm#112_fr For the veterinary
`product Convenia (EU/2/06/059) the URL could be http://ec.europa.eu/health/documents/community-
`register/html/v_direct_anx.htm#00059_nl for the latest annex in Dutch.
`
`If a wrong number is used or the link is used without a # sign the files redirect to the Community Register index
`page. If a language is chosen for which the annex does not exist, but it exists in other languages, you will be
`proposed to choose one of the existing languages (the interface language will be the language requested).
`
`Two letter ISO codes and EU languages:
`Finnish
`bg
`Bulgarian
`fi
`French
`cs
`Czech
`fr
`Croatian
`da Danish
`hr
`de German
`hu Hungarian
`el
`Greek
`it
`Italian
`en
`English
`lt
`Lithuanian
`es
`Spanish
`lv
`Latvian
`et
`Estonian
`mt Maltees
`
`nl
`pl
`pt
`ro
`sk
`sl
`sv
`
`
`Dutch
`Polish
`Portuguees
`Romanian
`Slovak
`Slovenian
`Swedish
`
`
`
`
`WHY IS IRISH (GAELIC) MISSING IN THE COMMUNITY REGISTER?
`
`
`Up to 31 December 2006, Irish was not included in the working languages of the EU institutions. Pursuant to an
`Agreement made in 1971 between Ireland and the Community, Irish was considered an official Community
`language, it being understood, however, that only primary legislation was drawn up in that language.
`
`
`WATSON LABORATORIES, INC. , IPR2017-01622, Ex. 1049, p. 12 of 13
`
`

`

`On 1 January 2007, Irish became a full EU official language, with a temporary derogation for a renewable period
`of five years (see Council Regulation (EC) No 920/2005 of 13 June 2005 (OJ L 156, 18.6.2005, p. 3)) stating that
`‘the institutions of the European Union shall not be bound by the obligation to draft all acts in Irish and to
`publish them in that language in the Official Journal of the European Union’, except for regulations adopted
`jointly by the European Parliament and the Council. This derogation has been extended for a period of five
`years (until 31 December 2016) by Council Regulation (EU) No 1257/2010 (OJ L 343, 29.12.2010, p. 5).
`
`
`WHAT ARE PRODUCTS REGISTERED UNDER ARTICLE 126A OF DIR 2001/83/EC?
`
`
`In order to increase availability of medicinal products, in particular on smaller markets, Article 126a of Directive
`2001/83/EC provides that, in the absence of a marketing authorisation or of a pending application for
`authorisation for a medicinal product, which has already been authorised in another Member State, a Member
`State may for justified public health reasons authorise the placing on the market of that medicinal product. In
`such cases, the competent authority of the Member State has to inform the marketing authorisation holder in
`the Member State in which the medicinal product concerned is authorised, of the proposal to authorise the
`placing on the market under this Article.
`The Commission shall amend the register of medicinal products accordingly and make this register
`available on their website.
`
`
`WHERE CAN I FIND MORE