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Mise en consultation de prescriptions techniques
Dans le cadre du procédé de notification UE/EFTA et OMC/TBT, nous vous informons des prescriptions techniques en
consultation. Si vous pensez que ces prescriptions peuvent créer des barrières dans le commerce transfrontalier, vous
avez la possibilité de donner votre avis.
Nous vous invitons à nous adresser vos commentaires et prises de position à l’adresse suivante au plus tard deux
semaines avant l’expiration du délai mentionné dans la notification:
Secrétariat d’Etat à l’économie SECO, Services spécialisés économie extérieure, Mesures non tarifaires,
Holzikofenweg 36, 3003 Bern, [email protected].
Le texte de notification complet peut être demandé dans la langue disponible auprès du secrétariat SNV,
téléphone 052 224 54 55, E-Mail : [email protected]
Vous trouverez toutes les 3000 notifications publiées chaque année dans notre base de données : http://www.snv.ch/fr/informations-de-lue-et-de-lomc/
Ce mois, l’équipe de rédaction SNV NEWS aimerait mentionner surtout les prescriptions suivantes :
Numéro / Pays
Titre
Contenu
Délai
CHL/297
Chile
Technical specifications for
the design of energy efficiency
labels for washing machines
(13 pages, in Spanish)
The notified technical specifications cover energy efficiency labelling for domestic
washing machines with or without heating devices and with a hot and/or cold water
supply. The specifications also apply to washing machines for communal use in
apartments or other buildings and laundries. They do not apply to washing machines
used in commercial laundries.
2015-04-01
COL/212
Colombia
Draft Ministry of Mining and
Energy Resolution "Issuing
the Technical Regulation on
rational energy-use labelling
for certain types of electrical
and gas end-use equipment,
for
marketing in Colombia"
(100 pages, in Spanish)
The notified draft Resolution covers the following: Purpose; General coverage; Scope;
Definitions; Abbreviations, symbols and acronyms; Labelling requirements for electrical
and gas end-use products; Specific product labelling requirements; Conformity
assessment; Monitoring and inspection bodies; Producer, supplier and retailer
registration; Transitional provisions; Penalty system; Regulation interpretation, review
and updating; Provision for requirements by other bodies; Inefficient equipment Prohibition on marketing for use in Colombia; and Period of validity.
2015-05-04
2015/47/DK
Denmark
Amendments to Order No 73
of 25 January 2013 on a
The amendments to the order concern submission deadlines for valid project
certificates. The deadline of "before commissioning" is changed to "no later than three
2015-05-04
2015-03-04
1
Numéro / Pays
Titre
Contenu
technical certification scheme
for wind turbines
months after commissioning". Limit values are also inserted in relation to the reporting of
servicing conducted on wind turbines. A few editorial amendments have
also been made.
The order contains certification requirements for wind turbines as well as servicing and
maintenance requirements with a view to ensuring both the wind turbine's durability
throughout its service life and its production of electricity for the collective grid.
EU/266
European Union
Draft Commission Regulation
amending Annex XVII to
Regulation (EC) No
1907/2006 of the European
Parliament and of the Council
on the Registration,
Evaluation, Authorisation and
Restriction of Chemicals
(REACH) as regards benzene
(3 pages + Annex 3 pages, in
English)
This draft Commission Regulation will revise the current entry 5 of Annex XVII to
REACH providing for an exemption for the content of benzene in natural gas.
2015-04-11
KOR/551
Republic of Korea
Regulation on the
Sub-Classification and Class
of Medical Devices
(60 pages, in Korean)
Rules for the sub-classification and class of medical device as provided in "Regulations
on the Sub-Class and Class of Medical Devices" are partially
amended as follows:
• Establishment of new products: 5 products including human milk analyser,
ultrasound gel, etc.;
• Revision of product name and definition: 285 products including pulse oximeter,
physical therapy paraffin wax bath, etc.;
• Sub-classification: 17 products including bladder volume measurement system, etc.;
• Revision of product class: 6 products. 4 products upward adjustment, 2 products
downward adjustment;
• Deletion: 8 products including dental laboratory casting unit, etc.
2015-04-02
KOR/552
Republic of Korea
Proposed
Regulation on Good
Manufacturing Practice for
Medicinal Products (229
pages, in Korean)
Content of this draft regulation is as follows:
• Detailed guidelines and principles of good manufacturing practice for medicinal
product are defined and mandated. Annexes from 1 to 16 to this regulation are
equivalent to the annexes of the PIC/S GMP Guide (except for Annexe 4, 5, 16 and
20 which are outside the jurisdiction of MFDS or are not required by PIC/S);
• For GMP Certificate of GMP Compliance of a Manufacturer, the effective period for an
initial certificate is 3 years from the date of issue and for subsequent certificates,
2015-04-04
2015-03-04
Délai
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Numéro / Pays
Titre
Contenu
Délai
and its effective period is also 3 years from the GMP inspection date. It is defined
that if there are any changes within the effective period of the certificate issued, the
existing period will still remain effective;
• Peritoneal Dialysis Solutions/Agents, Irrigations, Ophthalmic Solutions, Ophthalmic
Ointments, and Sterile API are added to the subject to evaluation of GMP compliance of
a manufacturer for approval of medicinal products even though GMP certificate is within
effective period.
KOR/559
Republic of Korea
2015-03-04
Amendment of "Regulations
on Approval, Notification and
Review of the Medical
Devices"
(66 pages, in Korean)
• Designate medical devices subject to mandatory clinical data submission: 63 product
items listed in Annex 12;
• For medical devices that have built-in software and/or consist of stand-alone
software, clarifies and streamlines the scope of performance data required for review
and approval;
• Extends the scope of attached documents for technical document review on sterility
test data of sterile medical devices(recognizes internationally harmonized sterility
assurance data);
• Enlarges the scope of Class I Second-hand Medical Devices which are exempt from
labelling a test certificate;
• Clarifies test items and submission data in technical documents for review and
approval;
• Streamlines and improves the method of writing STED: Summary Technical
Documentation (deletes redundant items, enables applicants to submit items
considering the original nature of products)
• Revises the requirements of clinical performance data of in-vitro diagnostics (IVDs).
2015-04-18
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