I sometimes get the urge to produce something creatively with my hands, and what often comes out of that are crowns of all sorts. This one feels like a fairy crown, with all the little foresty details.
I started by making a crown frame using brown wire with these little red buds. I rummaged through my craft materials and chose flowers and lace and stuff that complemented each other.
I glued on some glittery pieces of jewelry that I've had in store for years, but not found a use for.
A doily in center stage, surrounded by flowers and glitter.
I also glued on a trio of butterflies. I love the gray against the red and coral!
There's even a bird on this crown – perhaps a really tiny fairy bird who loves the flowers growing around the crown?
It felt so good to do something with my hands! And later on this spring, perhaps the crown will feature in an impromptu photo shoot if I find the inspiration.
I've been meditating for a while, and though I like to sit on a chair and meditate, or meditate out in the woods (can be uncomfortable or cold this time of year!) or sitting in my bed, I also sometimes want to just sit on the floor. But that position is not too good for long time meditating, which made me google meditation pillows. I found these instructions and made a pillow out of an old curtain fabric (a thrift shop find) and some gray fabric for pants that I got from my grandmother ages ago and never got around to do anything with. They turned out perfect for this project!
I used dried peas and cotton as filling, which works well because I get the stability I want from the peas, and softness from the cotton. The pillow also works perfectly for me when I sit and write. I still have aches after giving birth almost 15 years ago, and I usually have one of those plastic ergonomics pillows, but this one feels even better. This one I can mold until it is just the right fit for me.
It's been a while since I made the beeswax-covered cloths, and I never imagined we would use them as much as we do!
We pretty much wrap everything in them – leftover sweet potatoes that haven't yet been cooked, bowls of whipped cream and glasses filled with egg yolks. They're just so practical, and smell so good!
You can see the usage in them – the beeswax tends to gather in the folds, but that is easily remedied by a pair of warm hands.
We fold them and store them in a big bowl in the kitchen, ready for immediate use. And they smell so good! I keep going on about it, but it's just – there's something about beeswax that smells so delicious, and I'm happy my kids will associate this smell with their childhood!
I made another brooch made from recycled materials. I started with cutting out a heart shape out of cardboard, and then sewed a lot of white lace around it.
When the heart shape was covered, I sewed on a bow made out of a vintage ribbon, plus the key. Then I decorated it by sewing on freshwater beads. This was a really special brooch to make, especially as the person who received it had originally given the lace to me! I loved being able to use all these old materials for something new and meaningful.
There is something so satisfying about making something from stuff that is unloved, unused. And not only that – the new thing is even cuter than the original one! I stumbled upon descriptions for mittens made from old sweaters (google mitten sweaters, or check out pinterest or youtube for instructions – there are both videos and patterns to download), and I just had to try them. I used old cross stitch paintings for both pairs of mittens. The mittens are lined with fabric from an old fleece blanket and the cuff is made from an old sweater.
So fun to make, and so addictive!
I have a feeling we'll all be wearing cute upcycled mittens before this winter is over!
When I heard about people making their own reusable Bee's wraps, I knew that was a project I needed to try out. However, it turned out finding the right ingredients that the first recipe required wasn't that easy, so I kind of forgot about it. Until Apartment Therapy did a post about Reusable wraps. Their recipe seemed easy, but in the comment section I found an even easier method that suited me better so I tried out that.
1. I cut pieces of old, used fabric with pinking shears. I made some bigger pieces, some smaller ones. The exact measurements aren't that important – you can cut the fabric smaller afterward, and since the beeswax permeates the fabric, it will still work perfectly. Since the fabric will cover food, there is no point in using non-organic newly made fabric that is filled with chemicals, but older many-times-washed fabrics are perfect for this if you don't get your hands on some organic cotton.
2. I heated sheets of beeswax plus coconut oil in a bowl on one of our wood burning stoves, at about a 10:1 ratio. I would have used a double boiler if I hadn't already had this perfect place of melting wax. Our house smells wonderfully of beeswax now, by the way!
3. I dipped the fabric in the melted wax and used a pair of pincers to pick it up. Then I squeezed the extra wax off the fabric, trying not to burn myself in the process. I used a piece of undipped fabric for the squeezing.
4. Lastly, I held onto the fabric and waved it around in the air for a few seconds, letting the wax cool and set.
To use the fabric – just wrap it around the bowl and warm it with your hands. It should be a bit sticky so that it actually clings to the bowl or glass, so you might have to wash your hands afterwards.
You can wash off any food stains afterward with cold water and some soap – heat makes the wax melt off the fabric, but then again, if that happens you can always redo the process. Store the waxed fabrics in a drawer or a basket.
Super easy, so much fun to make and above all a practical way for us to limit the amount of cling film we use. Plus the waxed fabric looks really pretty!
Sometimes things end up in my home and wait for the right moment to be turned into something else.
I made this necklace using a handed down gray necklace with some lovely beads. I fastened keys to it using large links from an old broken necklace – it's much easier to do than you would think, once you get a handle on how pliers work.
And it's a great way to reuse old broken necklaces!
I wrapped black sparkly ribbon around a plain white headband, and fastened cogs and keys to it using some copper wire.
Now I only need to invent the dress that goes with these items!
I'm always looking for new ways of recycling things, and this time I got to use a few of all the buttons I've amassed during the years to make a button crown for my daughter.
I started by making a circlet out of some metal thread. I threaded a button on the thread and twisted it to form spikes.
I added more buttons to a piece of the metal thread and twisted it onto the crown. Then I just kept adding more and more buttons and pieces of thread until I felt the crown was almost finished.
As a last cute detail, I glued some peach and rose colored roses to the base of the crown, and placed an old fabric rose in the center.
A quick and easy crown to make!
I love old books. There is just something about really old book pages – perhaps the stories they have told, and the ephemeral about them? One day they are printed, sold and dispersed around the world, and the next they end up in a recycling bin. And if they do, I can't keep my hands off them!
One such old Danish book was recently turned into a bouquet of roses by me. I started by punching out leaves from the book pages. I glued them together two at a time, with a piece of wire in between.
Then I twined the pieces of wire into individual branches.
I cut out rose petals (I just cut them freehand in about three different sizes), glued them to a piece of wire, and then I twined the branches to the the rose stem.
Since winter here in Finland is still really dark, I placed my roses in a silver tea pot along with some fairy lights.
They look quite nice in the living room! The perfect addition for our house. DIY and pretty.


text:
Петрова — деревня в Гаринском городском округе Свердловской области России.

Географическое положение
Деревня Петрова муниципального образования «Гаринский городской округ» расположена в 8 километрах (по автотрассе в 9 километрах) к северо-северо-западу от посёлка Гари, на правом берегу реки Сосьва (левого притока реки Тавда). В деревне имеется озеро старичного происхождения.

Население

Примечания

Населённые пункты Гаринского городского округа

redpajama_set_name: RedPajamaWikipedia


Vase of black basalt, with 'encaustic' painting in red, white and black. Made in imitation of a Greek bell-shaped crater of the fourth century B.C. Decorated with a figure of an actor dancing beside a column and with bands of conventional ornament.
D'Hancarville, Pierre Antiquités étrusques, grecques et romaines Paris, 1787, Vol. 1, pl. 59.
A late eighteenth century design.


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Number of women arguing before the Supreme…
Number of women arguing before the Supreme Court has fallen off steeply
By Mark Walsh
August 1, 2018, 2:30 am CDT
Lisa Blatt: "You have to be not just fearless but aggressive." Photo by Arnold & Porter Kaye Scholer.
In this year's popular documentary RBG, Justice Ruth Bader Ginsburg reflects on, among other things, her years during the 1970s as an oral advocate before the Supreme Court, where she won five of the six cases she argued as a champion of women's rights.
"I did see myself as kind of a kindergarten teacher in those days because the judges didn't think sex discrimination existed," Ginsburg reflects in the film, which includes audio clips of sexist and patronizing comments by members of the then all-male court.
There has been change, of course, with four women having been appointed to the court, three of them serving together now. And female advocates at oral argument are not the rarities they were when Ginsburg last appeared in 1978.
However, Justices Ginsburg, Sonia Sotomayor, Elena Kagan and their male colleagues saw fewer women arguing before them in the 2017-18 term, and the fewest to participate in oral argument in at least seven years.
During the recently completed term, there were 19 appearances at oral argument by women, or about 12 percent of the total 163 appearances, according to statistics kept by Kedar Bhatia for SCOTUSblog. (There were 113 different advocates who argued for parties or amici in the 63 argued cases, with several lawyers appearing more than once.)
The 12 percent figure was a steep drop from the previous term (2016-17), when 21 percent of appearances at oral argument were by women. In the previous five years to that term, the participation rate for women ranged from a low of 15 percent to a high of 19 percent.
"The thing that's most disturbing to me is the consistency in the data," says Jennifer Crystal Mika, an adjunct professor at American University's Washington College of Law in the nation's capital, who has studied the issue of female advocates before the high court. "There has never been much more than 20 percent female advocates over the last 20 years."
SAME WORK, LESS PAY
It's a bit of an old story to some prominent female Supreme Court advocates, but one even they admit is worthy of continued discussion.
"I would have thought this would have been fixed by now," says Lisa S. Blatt, a partner with Arnold & Porter Kaye Scholer who has argued 35 cases—more than any other woman—before the Supreme Court.
In 2010, in the Green Bag online law journal, Blatt wrote an article about arguing before the justices in which she observed that men of the elite Supreme Court bar are more likely than women to represent corporate clients, while "the women I see arguing before the court are public interest lawyers, public defenders represent[ing] the criminally convicted or government lawyers. Translation: Women are doing the same work but for less pay."
Today, Blatt holds to her view that one reason men have maintained a stronghold on oral advocacy is that the courtroom is a battlefield where verbal jousting and sparring with the justices is rewarded.
"You have to be not just fearless but aggressive," she says.
This article was published in the August 2018 ABA Journal magazine with the title "Lost Ground: The number of women arguing before the court has fallen off steeply."
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News / Staff /
Paul Anthony Dennis, an associate professor of dance at the University of Massachusetts, Amherst, has been named the new chair of the Dance Department at Hunter College, it was announced today by Hunter College President Jennifer J. Raab. Professor Dennis, a former member of the Jose Limon Dance Company, is a respected scholar researching the relationship between dance and movement to neurodegenerative diseases.
"We welcome Paul Anthony Dennis to our faculty and look forward to his work as chair of the Dance Department, which is the only freestanding dance department in the City University of New York," said President Raab. "Paul shows that one person can really have it all. Not only is he a world-renowned international dancer, but he is a renowned educator and an impactful scholar himself. His academic and creative experience are well-suited to our program which provides a rigorous, challenging and humanistic dance education in a liberal arts environment."
Professor Dennis earned his BFA at the Juilliard School, and an MFA at Purchase College, Conservatory of Dance. While at UMass Amherst, he was also Associate Director of the White Mountains Summer Dance Festival, and a Five College faculty member, which enabled him to teach at Mount Holyoke, Amherst, and Hampshire Colleges. His career includes performances with Works/Laura Glenn Dance, Jacob's Pillow Men's Dancers: The Ted Shawn Legacy, Janis Brenner and Dancers, Scapegoat Garden, a 1995 White House performance and Florence's "White Nights Festival" at Palazzo Vecchio Salone De Cinquecento.
"Paul shows that one person can really have it all. Not only is he a world-renowned international dancer, but he is a renowned educator and an impactful scholar himself."
Hunter College President, Jennifer J. Raab
"I'm delighted to return to New York City and become a part of both the academic and cultural offerings in the Hunter College Dance Department," said Professor Dennis. "I was especially drawn to the cultural diversity of the students and faculty for which Hunter is known. In my positions at UMass Amherst and the Five College Dance, I worked on their Diversity, Equity and Inclusion (DEI) committee addressing white supremacy and racism in our classrooms, practices, pedagogies, institutions, and the broader dance field. I plan to bring the many lessons learned with me in my new role at Hunter."
In addition, Professor Dennis plans to introduce courses that reflect his academic interests in the relationship between dance and the health sciences.
"My own research into using dance for Huntington's Disease, as an example, reflects my interest in exploring collaborative avenues with other departments, with the goal of finding ways of bridging the gap between art and science," said Professor Dennis.
The Hunter College Dance Departments offers a BA and MFA in Dance, 5 year BA/MA and an MA in Dance Education with New York State K-12 certification. The curriculum provides students with a strong foundation that can lead to professional careers for performers, creators, scholars, educators, and arts advocates. Hunter Dance alumni have worked with artists and companies such as Bill T. Jones, Doug Varone, Pilobolus, Liz Lerman, Trisha Brown, Vicky Shick, Heidi Latsky, Pilobolus, director Peter Sellers, NY Baroque Dance Company, Phantom Limb, Camille A. Brown, Christal Brown, BodyCartography Project, SYTYCD, in various Broadway productions, and as independent choreographers. The Dance Department is known for the cultural diversity of the student population, the active, professional faculty, and the wide range of program opportunities.
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The grant will support scholarly groups at Hunter College's Center for Puerto Rican Studies to study issues confronting Puerto Rico and its diaspora.
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Jean Lichtenstein Kerner '39, having celebrated her 102nd birthday in March, is one of Hunter's oldest living alumna.
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Curated by Klaudia Ofwona Draber with associate curator Sofia Ramirez of KODA Organized by KODA and Hunter East Harlem Gallery Lina Puerta: ...
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In Virginia Inés Vergara's photographic series, Subductions, imagery suggesting geology, landforms, and earthly minerals intersect with her ...


I love Sangria. Let me rephrase, I love most Sangrias. We went to Hilton Head one year and I had the most perfect Sangria at a restaurant called Truffles. It was crisp, yet a little sweet and had the most amazing berries in it. Not a slice of orange and lime but loaded with blueberries, cherries and raspberries. Well, I was craving this drink on this hot summer day and set my mind to making it. Delightfully, it was all I had hoped it would be.
First, get all of your fruit washed and ready to cut. Obviously your berries need no preparation except for rinsing and tossing into the pitcher.
But your apple, peach and cherries all need chopping.
Toss into your pitcher with the berries. Clear pitchers are always nice too so you can see all the lovely colors mingling together. I realized when making this I do not have one. Note to self: get clear Sangria pitcher.
Add wine to the pitcher. My pitcher held almost the entire two bottles! The only bit left was the glass I poured myself.
At this point, I usually set it in the fridge for at least an hour to chill and let the flavors of the fruit incorporate into the wine and vice versa.
See how much darker the rim is with pretty color?
Pour into your favorite wine glass. Garnish with a sprig of mint.
And enjoy the hot day with this refreshing Sangria… Beba al sol.
Does the fruit 'pour' out too? Or do you have to ladle it out?
Pours 🙂 and leaving some in the bottom of your glass is the best part!


text:
EUR-Lex - 52020XC1223(03) - EN
Document 52020XC1223(03)
Commission notice – Application of the Union's pharmaceutical acquis in markets historically dependent on medicines supply from or through Great Britain after the end of the transition period 2020/C 447/05
OJ C 447, 23.12.2020, p. 10–15 (BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
C 447/10
Commission notice – Application of the Union's pharmaceutical acquis in markets historically dependent on medicines supply from or through Great Britain after the end of the transition period
Since 1 February 2020, the United Kingdom has withdrawn from the European Union and has become a 'third country' (1).The Withdrawal Agreement (2) provides for a transition period ending on 31 December 2020. Until that date, Union law in its entirety applies to and in the United Kingdom (3). This includes the pharmaceutical acquis of the Union, in particular Directive 2001/82 (4), Directive 2001/83 (5), Commission Delegated Regulation (EU) 2016/161 (6) and Article 13 of Directive 2001/20 (7), which are of relevance for this Notice.
At the end of the transition period, Union law ceases to apply to the United Kingdom. As the Protocol on Ireland and Northern Ireland ('the IE/NI Protocol') starts to apply, some Union legislation (including the above mentioned legislation), its implementing, amending and replacing measures, however, becomes applicable to and in the United Kingdom in respect of Northern Ireland in accordance with Art 5 (4), Annex 2, point 20, of the IE/NI Protocol.
In practical terms, this means, in particular, that:
Medicinal products (in the scope of the abovementioned legislation) placed on the market in Northern Ireland must comply with the regulatory requirements laid down in Union law (cf. Article 5 (4) of the IE/NI Protocol, read in conjunction with Annex 2 to that Protocol);
Medicinal products must have a valid marketing authorisation in the EU or in Northern Ireland, the holder of which is located in the EU or in Northern Ireland;
Trade in medicinal products from Great Britain to Northern Ireland or to the Union constitutes an import in the sense of applicable Union law;
Trade in medicinal products from the Union or Northern Ireland to any other part of the United Kingdom (Great Britain) or any other third country constitutes an export in the sense of applicable Union law;
Authorisations issued by UK authorities are, in principle, not valid under Union law, but can only be recognised in Northern Ireland if adopted in accordance with applicable Union law (cf. Article 7 (3) of the IE/NI Protocol);
Any steps in the supply of medicines which must be carried out in the Union (e.g. batch release) in order to allow for the placing on the market of medicinal products in accordance with Union law must occur in the (geographical) scope of Union law, ie in the Union or Northern Ireland, and only actions that may be carried out in third countries may occur in Great Britain.
The Commission and the European Medicines Agency have, since 2017, actively been disseminating all relevant information in order to draw the attention of all relevant stakeholders to the impact of the United Kingdom's withdrawal and to alert them of the need to adapt in time before the end of the transition period. The necessary changes have notably been explained in BREXIT Notices as last amended and published on 7 May 2020 for clinical trials (8) and on 13 March 2020 for medicinal products (9).
Nonetheless, some markets which have historically relied on supply of medicinal products from or through Great Britain (Cyprus, Ireland, Malta and Northern Ireland) (10), may still need some additional time to adapt supply chains and take account of the end of the transition period. Against that background, it is crucial that the Union's pharmaceutical acquis is implemented and enforced in a manner that both prevents shortages of medicines and ensures the high level of public health protection foreseen by Union law.
The Commission has identified the following challenges (described below) as the principal difficulties for the above-mentioned markets which are historically dependent on medicines supply from or through Great Britain in complying with the Union's pharmaceutical acquis:
Lack of operators holding a manufacturing authorisation necessary for imports of medicinal products from third countries;
Difficulties to carry out quality control testing ('batch testing');
Difficulties to comply with the provisions of Directive 2001/83/EC and Commission Delegated Regulation (EU) 2016/161 with respect to the placement and verification of the unique identifier.
Recognising these challenges, and taking into consideration the exceptional circumstances of the COVID-19 pandemic, the Commission takes note of the request, from both private and public stakeholders in the Union and the United Kingdom, for more time in the transition towards full compliance with the Union's pharmaceutical acquis.
1. Lack of operators holding a manufacturing authorisation required for importing medicinal products from third countries
A. Human and veterinary medicinal products
According to Article 40(3) of Directive 2001/83/EC and Article 44(3) of Directive 2001/82/EC, anyone placing medicinal products from third countries on the market in accordance with Union law (in the Union or in Northern Ireland) is an importer in the sense of Union law, and must therefore hold a manufacturing authorisation issued by the Member State where the importer is established or, in the case of importers established in Northern Ireland, by the UK acting in respect of Northern Ireland in accordance with Articles 41 and 42 of Directive 2001/83/EC for human medicines and/or Articles 45 and 46 of Directive 2001/82/EC for veterinary medicines. The conditions for such a manufacturing authorisation include, inter alia, the availability of a qualified person in the Union or Northern Ireland, the inspection of the manufacturer/importer and its compliance with Good Manufacturing Practices.
According to Articles 118 of Directive 2001/83/EC and Article 84(e) of Directive 2001/82/EC, competent authorities applying the Union's pharmaceutical acquis are obliged to suspend or revoke the marketing authorisation of a medicinal product where the holder of that authorisation does not have a valid manufacturing authorisation or does not comply with one of the conditions necessary to obtain such manufacturing authorisation.
In order to allow operators in these markets historically dependent on medicines supply from Great Britain additional time to comply in full with the requirements of the Union's pharmaceutical acquis in the exceptional circumstances of a global pandemic, the competent authorities of Ireland, Malta, Cyprus and the United Kingdom with respect to Northern Ireland could apply the following practice between January 2021 and 31 December 2021.
In this case, the competent authorities of Ireland, Malta, Cyprus and the United Kingdom with respect to Northern Ireland would allow medicinal products to be imported from Great-Britain by wholesalers which are not in possession of a manufacturing authorisation as required by Article 40 of Directive 2001/83/EC and Article 44 of Directive 2001/82; and they (ii) would not suspend or revoke the marketing authorisations of those medicinal products as required by Articles 118 of Directive 2001/83 and Articles 84(e) of Directive 2001/82, provided that the following conditions are fulfilled:
The medicinal products supplied from or through Great Britain and placed on the market in accordance with Union law (i.e. imported into the Union or Northern Ireland) have undergone quality control testing ('batch testing' (11)) either in the Union, as provided for in Article 51(3) of Directive 2001/83/EC for human medicinal products and in Article 44(3) of Directive 2001/82/EC for veterinary medicinal products, or in Great Britain in compliance with Article 20 (b) of Directive 2001/83/EC for human medicinal products and with Article 24b of Directive 2001/82/EC for veterinary medicinal products (see Section 2 of this Notice);
The medicinal products supplied from or through Great Britain and placed on the market in accordance with Union law (i.e. imported into the Union or Northern Ireland) have been subject to batch release by a Qualified Person (QP) in the Union or by a QP in the UK applying equivalent quality standards to those laid down in Union law, thus ensuring an equivalent level of protection of human health;
The operator placing medicinal products supplied from or through Great Britain on the market in accordance with Union law (in the Union or in Northern Ireland) holds a distribution authorisation issued, before the end of the transition period, in accordance with Article 77(1) of Directive 2001/83/EC for human medicinal products and/or Article 65(1)of Directive 2001/82/EC for veterinary medicinal products;
The marketing authorisation of the medicinal product concerned has been issued by the competent authority of an EU Member State, by the Commission, or by the competent authority of the United Kingdom before the end of the transition period and in accordance with Union law;
The medicinal products supplied from or through Great Britain are made available to the end consumer in the same market historically dependent on medicines supply from Great Britain where they are imported, and they are not made available in other EU Member States.
The competent authorities of Ireland, Malta, Cyprus and the United Kingdom with respect to Northern Ireland would in this case also report to the Commission, on a monthly basis, as regards the progress made by wholesale distributors importing medicinal products in fulfilling the conditions necessary to obtain a manufacturing authorisation laid down in Article 41 of Directive 2001/83/EC and Article 45 of Directive 2001/82/EC, including, in particular, the conclusion by those wholesale distributors of contractual relationships with qualified persons in the Union.
B. Investigational medicinal products
According to Article 13 of Directive 2001/20/EC, the placing on the market of investigational medicinal products from third countries in accordance with Union law also requires the importer to hold a manufacturing authorisation. After the end of the transition period, this also applies to the supply of investigational medicinal products from or through Great Britain in Cyprus, Ireland, Malta and Northern Ireland. Similarly to the requirements for manufacturing authorisations pursuant to Article 41 of Directive 2001/83 and Article 44 of Directive 2001/82, Article 13(2) of Directive 2001/20/EC also requires the holder of this manufacturing authorisation to have, permanently and continuously, at his disposal the services of at least one qualified person in the scope of application of Union law, i.e. in the Union or in Northern Ireland.
In order to allow operators in these markets historically dependent on medicines supply from Great Britain additional time to comply in full with the requirements of the Union's pharmaceutical acquis in the exceptional circumstances of a global pandemic, the competent authorities of Ireland, Malta, Cyprus and the United Kingdom with respect to Northern Ireland could apply the following practice between January 2021 and 31 December 2021 as regards investigational medicinal products.
In this case, the competent authorities of Ireland, Malta, Cyprus and the United Kingdom with respect to Northern Ireland would allow investigational medicinal products to be imported from Great-Britain by wholesalers which are not in possession of a manufacturing authorisation as required by Article 13 of Directive 2001/20/EC, provided that the following conditions are fulfilled:
The medicinal products supplied from or through Great Britain and approved for use in accordance with Union law (i.e. imported into the EU or Northern Ireland) have undergone batch release either in the Union, as provided for in Article 13(3) of Directive 2001/20, or in Great Britain in compliance with Article 13(3) of Directive 2001/20/EC;
The clinical trials authorisation of the medicinal product concerned has been issued by the competent authority of an EU Member State, by the Commission, or by the United Kingdom before the end of the transition period and in accordance with Union law;
The competent authorities of Ireland, Malta, Cyprus and the United Kingdom with respect to Northern Ireland would in this case also report to the Commission, on a monthly basis, as regards progress made by operators importing investigational medicinal products in fulfilling the conditions necessary to obtain a manufacturing authorisation pursuant to Article 13 of Directive 2001/20/EC, including, in particular, the conclusion by those operators of contractual relationships with qualified persons in the Union.
2. Batch testing of human and veterinary medicinal products
According to Article 51(1)(b) of Directive 2001/83/EC and Article 55(1)(b) of Directive 2001/82/EC, medicinal products imported into the EU have to undergo quality control testing ('batch testing') in the EU/EEA. The requirement of a batch release site established in the Union is a fundamental pillar of the Union system of ensuring quality of medicinal products being placed on the Union market. However, with regard to the quality control testing there may be objective reasons beyond the control of the marketing authorisation holders that may have prevented the timely transfer of such testing activities to be carried out in the Union or Northern Ireland by the end of the transition period.
In these cases, Article 20(b) of Directive 2001/83/EC and 24(b) of Directive 2001/82/EC allow for importers placing medicinal products supplied from or through Great Britain on the market in Cyprus, Ireland, Malta or Northern Ireland or wholesale distributors placing such medicinal products on those markets as described under Section 1 above, to have, in justifiable cases, certain controls carried out in Great Britain. Taking into account the exceptional circumstances described in this Notice, the Commission considers that a 'justifiable case' within the meaning of Article 20(b) Directive 2001/83/EC and 24(b) of Directive 2001/82/EC occurs when the following conditions are fulfilled:
Each batch of the medicinal product concerned is released by a qualified person (QP) on a site in the EU or by a QP on a site in the UK applying equivalent quality standards to those laid down in Union law, thus ensuring an equivalent level of protection of human or animal health, in cases falling under Section 1 above;
The establishment designated by the third party conducting the quality control testing is supervised by a competent authority, including on-the-spot checks. Demonstrable progress towards transferring the quality control testing site to the Union or Northern Ireland is shown. Notably the batch testing site should be established within a twelve-month period after the end of the transition period, by the 31 December 2021 at the latest.
In order to make use of the derogation foreseen in Article 20(b) of Directive 2001/83/EC for human medicinal products and Article 24(b) of Directive 2001/82/EC for veterinary medicinal products, marketing authorisation holders should notify the competent authority that granted the marketing authorisation of the product concerned (Cyprus, Ireland, Malta or Northern Ireland), specifying that – and why in their view - the above criteria of a 'justifiable case' in the sense of Article 20 (b) of Directive 2001/83, and of Article 24 (b) of Directive 2001/82, are fulfilled. For medicinal products to be placed on the market in Northern Ireland, the competent authority is the MHRA. For centrally authorised products, the competent authority is EMA.
Any such notification should be submitted without undue delay and should be received as soon as possible after the end of the transition period, and in no case later than by 30 January 2021.
3. Requirements relating to the placement of the unique identifier for medicinal products for human use
As the IE/NI Protocol makes Directive 2001/83 applicable to and in the United Kingdom in respect of Northern Ireland in its current version, the safety features (namely the anti-tampering device and the unique identifier) laid down in Articles 54 (o) and 54a (1) of Directive 2001/83/EC also apply to medicinal products placed on the market in Northern Ireland. Without prejudice to the application of this Union legislation to and in the United Kingdom in respect of Northern Ireland, the placing on the market of medicinal products in any other part of the United Kingdom than Northern Ireland will not require the use of these safety features, like the unique identifier, foreseen in Union law.
This means that, as from 1 January 2021, packs of medicines destined for Great Britain should be separated from packs destined for Cyprus, Ireland, Malta or Northern Ireland – even where the supply route goes through Great Britain. Like for any medicinal products placed on the market in the Union, the information of the Cypriot, Irish, Maltese and Northern Irish packs needs to be uploaded in the European hub, or the repository systems of the respective territories, but not the information of the packs with a final destination in any other part of the United Kingdom than Northern Ireland (Great Britain).
As regards packs exported from the Union to any third country like the United Kingdom, Article 22 of Commission Delegated Regulation (EU) 2016/161 obliges the economic operator exporting the medicinal products to decommission any unique identifier that may have already been affixed to the pack prior to the export.
Where medicinal products are supplied, through Great Britain, to Cyprus, Ireland, Malta or Northern Ireland, it would then, in principle, be for the importer holding a manufacturing authorisation to affix a new unique identifier on the medicinal products in question when they are placed on the market (cf. Article 4 of Commission Delegated Regulation (EU) 2016/161). Nevertheless, there are currently no importers holding a manufacturing authorisation located in Cyprus, Ireland, Malta and Northern Ireland with capacity to meet the obligation to affix a new unique identifier as required by Union law as of 1 January 2021 so that compliance would be practically impossible. At the same time, allowing medicinal products without safety features on the Union market must be prevented, in order to ensure a high level of public health protection and to avoid the presence of falsified medicinal products in the Union.
The Commission therefore intends to amend Article 22 of Commission Delegated Regulation (EU) 2016/161 to address this situation.
The economic operators responsible for the export of medicinal products (placed on the market in the Union, exported to Great Britain and then imported into Cyprus, Ireland, Malta or Northern Ireland) from the Union to Great Britain would then no longer be obliged to decommission the unique identifier in accordance with Article 22 of Commission Delegated Regulation (EU) 2016/161.
Following this approach, the competent authorities of Ireland, Malta, Cyprus and the United Kingdom with respect to Northern Ireland would allow the import of medicinal products from Great Britain bearing non-decommissioned unique identifiers provided that the following conditions are fulfilled:
the wholesale distributor or the marketing authorisation holder established in the Union and responsible for the export of the medicinal product to the United Kingdom has verified the unique identifier against the European repository or the national repository system;
the wholesale distributor importing the product into Northern Ireland, Ireland, Cyprus or Malta has verified the unique identifier against the European repository or the national repository system;
The competent authorities of Ireland, Malta, Cyprus and the United Kingdom with respect to Northern Ireland would in this case also report to the Commission, on a monthly basis, as regards the progress made by wholesale distributors importing medicinal products in fulfilling the obligations under Directive 2001/83 and Commission Delegated Regulation (EU) 2016/161 relating to placement of the unique identifier.
(1) A third country is a country not member of the EU.
(2) Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community (OJ L 29, 31.1.2020, p. 7) ('Withdrawal Agreement').
(3) Subject to certain exceptions provided for in Article 127 of the Withdrawal Agreement, none of which is relevant in the context of this notice.
(4) Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001, p. 1).
(5) 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 (OJ L 311, 28.11.2001, p. 67).
(6) Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use (OJ L 32, 9.2.2016, p. 1).
(7) Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (OJ L 121, 1.5.2001, p. 34).
(8) https://ec.europa.eu/info/sites/info/files/brexit_files/info_site/clinical-trials_en.pdf
(9) https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/notice-stakeholders-withdrawal-united-kingdom-eu-rules-medicinal-products-human-use-veterinary_en.pdf
(10) These Member States are singled out in this Notice because of their historical dependence on the UK market for their supply of medicinal products and the fact that a large proportion of their imports of medicinal products is coming from UK.
(11) According to Article 51(1)(b) of Directive 2001/83/EC and Article 55(1)(b) of Directive 2001/82/EC, medicinal products imported into the EU have to undergo quality control testing ('batch testing') in the EU/EEA. These provisions prescribe that in the case of medicinal products coming from third countries, irrespective of whether the product has been manufactured in the Union, that each production batch has undergone in a Member State a full qualitative analysis, a quantitative analysis of at least all the active substances and all the other tests or checks necessary to ensure the quality of medicinal products in accordance with the requirements of the marketing authorisation.


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Q: Error: Cannot find primary outlet to load 'DashboardComponent'? I tried to solve this issues but I couldn't.
I am new in angular 2. i am creating an app.
But got this error, can anyone suggest me that where i am doing wrong ?
Error is:
EXCEPTION: Uncaught (in promise): Error: Cannot find primary outlet to load 'DashboardComponent'
My Code is:
app.component.ts
import { Component } from '@angular/core';
@Component({
  selector: 'my-app',
  moduleId: module.id,
  styleUrls: ['app.component.css'],
  template: `
{{title}}

    Dashboard
    Heroes

`,
})
export class AppComponent {
  title = 'Tour of Heroes';
}

dashboard.component.ts
import { Component, OnInit } from '@angular/core';
import { Hero } from './hero';
import { HeroService } from './hero.service';

@Component({
    moduleId:module.id,
    selector:'my-dashboard',
    templateUrl: 'dashboard.component.html',
    styleUrls: [ 'dashboard.component.css' ]

})
export class DashboardComponent implements OnInit{
 heroes: Hero[] = [];
  constructor(private heroService: HeroService) { }
  ngOnInit(): void {
    this.heroService.getHeroes()
      .then(heroes => this.heroes = heroes.slice(1, 5));
  }
 }

app-routing-module.ts
import { NgModule }             from '@angular/core';
import { RouterModule, Routes } from '@angular/router';
import { DashboardComponent }   from './dashboard.component';
import { HeroesComponent }      from './heroes.component';
import { HeroDetailComponent }  from './hero-detail.component';
import { ShubhComponent } from './my.component';
import { MyComponent } from './my.component';

const routes: Routes = [
  { path: '', redirectTo: '/dashboard', pathMatch: 'full' },
  { path: 'dashboard',  component: DashboardComponent },
  { path: 'detail/:id', component: HeroDetailComponent },
  { path: 'heroes',     component: HeroesComponent }
];
@NgModule({
  imports: [ RouterModule.forRoot(routes) ],
  exports: [ RouterModule ]
})
export class AppRoutingModule {}

A: You should define a <router-outlet>. Your AppComponent template is missing this tag. This tag is necessary to let the router know where to insert your components defined in your routing module:
@Component({
  selector: 'my-app',
  moduleId: module.id,
  styleUrls: ['app.component.css'],
  template: `
{{title}}

    Dashboard
    Heroes

  <router-outlet></router-outlet>
`,
})
export class AppComponent {
  title = 'Tour of Heroes';
}

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